7,187 Professional Standards jobs in the United States
Administrative Analyst (Professional Standards Unit)
95828 Florin, California
City of Sacramento, CA
Posted 1 day ago
Job Viewed
Job Description
Salary : $75,027.68 - $105,571.48 Annually
Location : Sacramento, CA
Job Type: Full-Time Career
Job Number: 010700-25-FD-2
Department: Fire
Division: Departmental Investigations
Opening Date: 08/22/2025
Closing Date: 9/5/2025 11:59 PM Pacific
THE POSITION
With supervisor approval, incumbents may be eligible for intermittent remote work; however, they must physically reside within the Sacramento region or have the ability to regularly report to a City of Sacramento physical worksite with little notice.
The City of Sacramento Fire Department is excited to announce an opportunity within its Professional Standards Unit (PSU). This role involves highly analytical and technical work supporting the administrative management of grievances, discipline documentation and tracking, and adherence to the Firefighter Bill of Rights. The position plays a vital role in fostering strong relationships with key partners, including City Human Resources, the Office of Public Safety Administration, the Firefighter Union, and various state and federal agencies.
IDEAL CANDIDATE STATEMENT
The ideal candidate will have exceptional attention to detail and the ability to manage strict deadlines while effectively prioritizing time-sensitive and highly confidential tasks. They will be adaptable, able to pivot with shifting priorities, and skilled in research, technical writing, and interpreting statutes, regulations, policies, and procedures in Labor Relations.
The ideal candidate will provide administrative support by tracking and maintaining records of written discipline, preparing Skelly packets, and coordinating and supporting the processing of internal and external complaints or concerns.
This journey-level classification is populated with multiple incumbents. Incumbents may be assigned to perform either the entire range of support functions and administrative and technical duties for a division or department or a broad range of functional program management duties for programs with department or Citywide impact. Responsibilities require a complete knowledge of departmental policies, programmatic, or project operating policies and procedures. The Administrative Analyst may specialize in one program area or may have broader responsibility for multiple internal service functions. Incumbents may independently perform moderately complex professional or program management work and make independent decisions on routine activities; or may perform complex professional or program management work under closer direction and exercise less independent judgment and discretion. The Administrative Analyst is distinguished from the next higher-level class of Administrative Officer in that the latter is responsible for the administration and management of programs and projects or all centralized administrative services for a department or major division with high visibility and substantial Citywide impact.
SUPERVISION RECEIVED AND EXERCISED
General direction is provided by higher-level department or division administrative personnel. Responsibilities may include the indirect supervision of technical and clerical personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Knowledge of:
Skill in:
Ability to:
EXPERIENCE AND EDUCATION
Experience:
Two years of full-time paid or other equivalent experience performing as a para-professional as it relates to report writing, research, analysis, or technical support in the areas of administration, program management or system operations.
And
Education:
A Bachelor's Degree from an accredited college or university with major coursework in public or business administration, economics, accounting, personnel, or a closely related field.
Substitution of Education:
An additional four years of full-time paid or other equivalent experience performing as a para-professional as it relates to report writing, research, analysis, or technical support in the areas of administration, program management, or system operations may substitute for the required education.
PROOF OF EDUCATION
Should education be used to qualify for this position, then proof of education such as, but not limited to, university/college transcripts and degrees should be submitted with your application and will be required at the time of appointment . Unofficial documents and/or copies are acceptable.
An applicant with a college degree obtained outside the United States must have education records evaluated by a credentials evaluation service. Evaluation of education records will be due at time of appointment.
SPECIAL QUALIFICATIONS
Special Selection Criteria:
Some positions in this classification may require additional knowledge and experience in the following:
Employees must complete twelve (12) months of probation at a satisfactory performance level prior to gaining permanent status.
THE SELECTION PROCEDURE
P lease note, the City of Sacramento's preferred method of communication with applicants is via e-mail. As such, please ensure you verify the e-mail address on your application, and check your e-mail frequently, including your spam and junk folders. All e-mail notifications can also be accessed through the governmentjobs.com applicant inbox.
1. Application: (Pass/Fail) - All applicants must complete and submit online a City of Sacramento employment application by the final filing deadline;
4. Screening Committee : (Pass/Fail)- All candidates that pass the examination and are in one of the top three ranks will have their application forwarded to the hiring department for review. The hiring department will select the most competitive applications for further consideration. Human Resources will only evaluate employment applications for the minimum qualifications, as stated on the job announcement, for applications selected by the hiring department.
5. Conditional Hire: Upon receipt of a conditional offer, the selected candidate must complete and pass Live Scan/fingerprinting. If applicable, candidates may also need to pass a pre-employment medical exam, controlled substance and/or alcohol test, and possess any required licensure or certification prior to receiving a start date from the Department. Failure to meet these prerequisites will be grounds for withdrawal of your conditional offer of employment.
QUESTIONS:
For questions concerning this job announcement and the application process:
Bilingual Pay
Did you know that the City offers bilingual pay? That's right, most labor agreements offer the option of providing employees with bilingual pay if the department deems it to be operationally necessary.
Pension Reform Act
The City of Sacramento is covered by the California Public Employees' Retirement System, and as such, must adhere to the California Public Employee's Pension Reform Act (PEPRA) of 2013. Please note that the provisions within this act may affect or impact an applicant's eligibility and/or selection for open vacancies at the City of Sacramento.
Equal Opportunity Employer
The City of Sacramento is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.
Additional Information
Civil Service Rules:
Union Contracts:
Salary Schedule:
01
APPLICATION : I understand my application must meet the minimum qualifications for consideration of employment with the City of Sacramento. The experience I list in the duties area of the "Work Experience" section of the employment application will be used to determine if I meet the minimum qualifications as stated on the job announcement. A resume, responses to the supplemental questions requiring a narrative response, employment history listed elsewhere in the application or attachments will not substitute for the information required in the "Work Experience" section of the employment application. Position/job titles will not be considered in determining eligibility for meeting the minimum qualifications for this position. Note: Qualifying experience is based on full-time experience (40 hours per week). Qualifying experience is calculated to the full-time equivalent (pro-rated if less than 40 hours/week).Please refer to the City of Sacramento's Applicant Resources Page for Screening Instructions:
02
PROOF OF EDUCATION: To qualify for this classification you may use education or experience as listed in the substitution option to provide required knowledge, skills, and abilities.I understand proof of education such as, but not limited to, university/college transcripts and degrees should be submitted with my application and will be required at the time of appointment if I am using education to qualify for this position.Please refer to the City of Sacramento's Proof of Education Requirements ( for information on accepted documentation.
03
EDUCATION CONFIRMATION: If I am using education to qualify for this position, I attest I possess or will possess a Bachelor's Degree from an accredited college or university with major coursework in public or business administration, economics, accounting, personnel, or a closely related field by time of appointment if I am selected for the position.
04
SUPPLEMENTAL QUESTIONNAIRE : The answers to the questions below will be reviewed by the hiring department along with the information provided in your employment application. Therefore, your answers must be consistent with your employment application information (especially in the "Education" and "Work Experience" sections), must be unambiguous, and must contain sufficient but concise detail and organization. A resume will not be accepted in lieu of completing this Supplemental Questionnaire. Lack of clarity, incomplete or inconsistent information, and/or disorganized presentation may negatively affect the hiring department's review of your Supplemental Questionnaire. I understand and agree to the above instructions.
05
This role requires coordination with internal and external stakeholders. Describe your experience providing effective communication and collaboration across departments and agencies.
06
Describe your experience with report writing and data analysis. Include methods of research, how the work was checked for accuracy, and how the work was presented.
07
Describe your experience handling confidential information and how you ensure security and professionalism.
08
TRAINING AND EXPERIENCE EXAMINATION : The following questions are the Training and Experience (T&E) Examination. In addition to the City of Sacramento employment application, applicants must complete and submit online responses to the T&E questions. This exam will evaluate the relevance, level, and progression of a candidate's education, training and experience. Therefore, your responses to the T&E Exam questions should be thorough and complete because the exam score will determine your ranking on the eligible list for this job. In accordance with the City of Sacramento's Racial and Gender Equity Action Plan (RGEAP), this examination contains non-binary names and pronouns. For additional information regarding the City's RGEAP, please copy and paste the following link into a web browser: understand and agree to the above instructions.
09
Select the one option that best describes your experience assisting with analyzing and interpreting information for administrative and/or operational procedural recommendations.
10
Select all the boxes that best describe the software programs you are proficient in and use on a regular basis in the administration of your job and/or education.
11
Select the one option that best describes your experience writing comprehensive reports which included your recommendation based on supportive information or data.
12
Select the one option that best describes your experience performing research and conducting surveys for potential solutions to administrative and/or operational issues or concerns.
13
Select the one option that best describes your experience establishing and maintaining effective working relationships with leadership, colleagues, and stakeholders to move new procedures or objectives forward.
Required Question
Location : Sacramento, CA
Job Type: Full-Time Career
Job Number: 010700-25-FD-2
Department: Fire
Division: Departmental Investigations
Opening Date: 08/22/2025
Closing Date: 9/5/2025 11:59 PM Pacific
THE POSITION
With supervisor approval, incumbents may be eligible for intermittent remote work; however, they must physically reside within the Sacramento region or have the ability to regularly report to a City of Sacramento physical worksite with little notice.
The City of Sacramento Fire Department is excited to announce an opportunity within its Professional Standards Unit (PSU). This role involves highly analytical and technical work supporting the administrative management of grievances, discipline documentation and tracking, and adherence to the Firefighter Bill of Rights. The position plays a vital role in fostering strong relationships with key partners, including City Human Resources, the Office of Public Safety Administration, the Firefighter Union, and various state and federal agencies.
IDEAL CANDIDATE STATEMENT
The ideal candidate will have exceptional attention to detail and the ability to manage strict deadlines while effectively prioritizing time-sensitive and highly confidential tasks. They will be adaptable, able to pivot with shifting priorities, and skilled in research, technical writing, and interpreting statutes, regulations, policies, and procedures in Labor Relations.
The ideal candidate will provide administrative support by tracking and maintaining records of written discipline, preparing Skelly packets, and coordinating and supporting the processing of internal and external complaints or concerns.
This journey-level classification is populated with multiple incumbents. Incumbents may be assigned to perform either the entire range of support functions and administrative and technical duties for a division or department or a broad range of functional program management duties for programs with department or Citywide impact. Responsibilities require a complete knowledge of departmental policies, programmatic, or project operating policies and procedures. The Administrative Analyst may specialize in one program area or may have broader responsibility for multiple internal service functions. Incumbents may independently perform moderately complex professional or program management work and make independent decisions on routine activities; or may perform complex professional or program management work under closer direction and exercise less independent judgment and discretion. The Administrative Analyst is distinguished from the next higher-level class of Administrative Officer in that the latter is responsible for the administration and management of programs and projects or all centralized administrative services for a department or major division with high visibility and substantial Citywide impact.
SUPERVISION RECEIVED AND EXERCISED
General direction is provided by higher-level department or division administrative personnel. Responsibilities may include the indirect supervision of technical and clerical personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Performs professional analytical and technical work in the formulation and administration of department or division budgets, development, and management of grants and contracts, management of department level procurement, or coordination of personnel functions.
- Performs research and analysis in the development of program or project activities, including program compliance and eligibility, regulatory issues, and funding requirements.
- Compiles and analyzes data and makes recommendations on the formulation of policy, procedures, staffing, and organizational changes; conducts surveys and performs research and statistical analysis on administrative, fiscal, personnel, or operational problems.
- Compiles materials and assists in the preparation of program-related grants, budgets, reports, manuals, and publications; coordinates procurement activities and related support functions for a program or project.
- Analyzes information for preparation of grants, contracts, and agreements; assists in negotiating terms; implements, monitors, and prepares reports on conduct and performance; prepares statistical data and graphs.
- Performs research and prepares studies as required; conducts surveys, compiles and analyzes data and formulates program policies and procedures; monitors and evaluates program effectiveness and outcomes; prepares periodic or specialized reports of program activities.
- Participates and assists in the design, implementation, and installation of new and revised programs, systems, procedures, methods of operation, and forms.
- Coordinates and monitors the administrative functions of an assigned department; compiles materials and assists in the preparation of budgets, reports, manuals, and publications.
- Coordinates departmental activities and programs with other City departments and divisions, and with outside agencies; represents the assigned department in committee meetings; oversees contract service providers.
- Responds to complaints and requests for information; interprets and applies policies and procedures; adjudicates complaints.
- Makes complex program or project eligibility determinations; conducts focus groups; meets with community or business groups.
- Prepares oral reports; makes oral presentations to a variety of City and departmental committees.
- May train staff as assigned.
- Provides exceptional customer service to those contacted in the course of work.
- Other related duties may also be performed; not all duties listed are necessarily performed by each individual holding this classification.
Knowledge of:
- Principles and practices of personnel administration.
- Principles and practices of organization and public administration.
- Principles and practices of program management, analysis, and coordination.
- Principles and practices of program performance measurement, systems analysis, and statistical measurement.
- Research techniques, methods, and procedures, and basic methods of statistical analysis.
- Principles, methods, and practices of municipal finance, budgeting, and accounting.
- Principles, methods, and practices of procurement, contracting, and grant writing.
- Methods of reporting information.
- Applicable Federal, State, and local laws and regulations.
Skill in:
- Providing customer service, including dealing with people in sensitive situations and problem resolution.
- Making presentations and conducting meetings.
- Use of computers, computer applications, and software.
Ability to:
- Interpret and apply rules, regulations, laws, ordinances, and policies.
- Communicate effectively, both orally and in writing.
- Administer assigned program responsibilities.
- Collect and analyze data and make sound recommendations.
- Review organizational and administrative problems; recommend and implement appropriate courses of action.
- Establish and maintain effective working relationships with employees, the general public, and others contacted in the course of work.
- Review and analyze organizational and administrative problems; recommend and implement effective courses of action.
- Interpret laws, rules, regulations, policies, and procedures and make appropriate decisions.
- Meet multiple deadlines.
EXPERIENCE AND EDUCATION
Experience:
Two years of full-time paid or other equivalent experience performing as a para-professional as it relates to report writing, research, analysis, or technical support in the areas of administration, program management or system operations.
And
Education:
A Bachelor's Degree from an accredited college or university with major coursework in public or business administration, economics, accounting, personnel, or a closely related field.
Substitution of Education:
An additional four years of full-time paid or other equivalent experience performing as a para-professional as it relates to report writing, research, analysis, or technical support in the areas of administration, program management, or system operations may substitute for the required education.
PROOF OF EDUCATION
Should education be used to qualify for this position, then proof of education such as, but not limited to, university/college transcripts and degrees should be submitted with your application and will be required at the time of appointment . Unofficial documents and/or copies are acceptable.
An applicant with a college degree obtained outside the United States must have education records evaluated by a credentials evaluation service. Evaluation of education records will be due at time of appointment.
SPECIAL QUALIFICATIONS
Special Selection Criteria:
Some positions in this classification may require additional knowledge and experience in the following:
- Auditing principles.
- Basic methods of statistical analysis.
- Procurement, contracting, or grant writing.
Employees must complete twelve (12) months of probation at a satisfactory performance level prior to gaining permanent status.
THE SELECTION PROCEDURE
P lease note, the City of Sacramento's preferred method of communication with applicants is via e-mail. As such, please ensure you verify the e-mail address on your application, and check your e-mail frequently, including your spam and junk folders. All e-mail notifications can also be accessed through the governmentjobs.com applicant inbox.
1. Application: (Pass/Fail) - All applicants must complete and submit online a City of Sacramento employment application by the final filing deadline;
- Employment applications must be submitted online; paper applications will not be accepted.
- Employment applications will be considered incomplete and will be disqualified:
- If applicants do not list current and/or past job-related experience in the duties area of the "Work Experience" section. Note: Qualifying experience is based on full-time experience (40 hours per week). Qualifying experience is calculated to the full-time equivalent (pro-rated if less than 40 hours/week).
- If "see resume" is noted in the "Work Experience" section; a resume will not substitute for the information required in the "Work Experience" section.
- Proof of education such as, but not limited to, university/college transcripts and degrees should be submitted online with your application. Proof of education will be required at time of appointment.
- Position/job titles will not be considered in determining eligibility for meeting the minimum qualifications for this position.
- If you're requesting Veteran's credit, a copy of your DD214 must be submitted online with your application or emailed to the Employment Office by the final filing deadline. Information regarding the use of Veteran's credit can be found in the Civil Service Board rules under rule
- Applicants are responsible for attaching a copy of their DD214 to each position for which they apply.
- Responses to the T&E questions must be submitted online; paper questionnaires will not be accepted.
- A resume will not substitute for the information required in the T&E questions.
4. Screening Committee : (Pass/Fail)- All candidates that pass the examination and are in one of the top three ranks will have their application forwarded to the hiring department for review. The hiring department will select the most competitive applications for further consideration. Human Resources will only evaluate employment applications for the minimum qualifications, as stated on the job announcement, for applications selected by the hiring department.
5. Conditional Hire: Upon receipt of a conditional offer, the selected candidate must complete and pass Live Scan/fingerprinting. If applicable, candidates may also need to pass a pre-employment medical exam, controlled substance and/or alcohol test, and possess any required licensure or certification prior to receiving a start date from the Department. Failure to meet these prerequisites will be grounds for withdrawal of your conditional offer of employment.
QUESTIONS:
For questions concerning this job announcement and the application process:
- Please visit for a comprehensive, step-by-step guide to the application process.
- For technical support between 6 AM - 5 PM PT, contact Live Applicant Support at ( .
- Visit the City of Sacramento Human Resources Department website at ;
- Send an email to ; or
- Call the Human Resources Department at (
Bilingual Pay
Did you know that the City offers bilingual pay? That's right, most labor agreements offer the option of providing employees with bilingual pay if the department deems it to be operationally necessary.
Pension Reform Act
The City of Sacramento is covered by the California Public Employees' Retirement System, and as such, must adhere to the California Public Employee's Pension Reform Act (PEPRA) of 2013. Please note that the provisions within this act may affect or impact an applicant's eligibility and/or selection for open vacancies at the City of Sacramento.
Equal Opportunity Employer
The City of Sacramento is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.
Additional Information
Civil Service Rules:
Union Contracts:
Salary Schedule:
01
APPLICATION : I understand my application must meet the minimum qualifications for consideration of employment with the City of Sacramento. The experience I list in the duties area of the "Work Experience" section of the employment application will be used to determine if I meet the minimum qualifications as stated on the job announcement. A resume, responses to the supplemental questions requiring a narrative response, employment history listed elsewhere in the application or attachments will not substitute for the information required in the "Work Experience" section of the employment application. Position/job titles will not be considered in determining eligibility for meeting the minimum qualifications for this position. Note: Qualifying experience is based on full-time experience (40 hours per week). Qualifying experience is calculated to the full-time equivalent (pro-rated if less than 40 hours/week).Please refer to the City of Sacramento's Applicant Resources Page for Screening Instructions:
- Yes
02
PROOF OF EDUCATION: To qualify for this classification you may use education or experience as listed in the substitution option to provide required knowledge, skills, and abilities.I understand proof of education such as, but not limited to, university/college transcripts and degrees should be submitted with my application and will be required at the time of appointment if I am using education to qualify for this position.Please refer to the City of Sacramento's Proof of Education Requirements ( for information on accepted documentation.
- Yes
03
EDUCATION CONFIRMATION: If I am using education to qualify for this position, I attest I possess or will possess a Bachelor's Degree from an accredited college or university with major coursework in public or business administration, economics, accounting, personnel, or a closely related field by time of appointment if I am selected for the position.
- Yes
- No
04
SUPPLEMENTAL QUESTIONNAIRE : The answers to the questions below will be reviewed by the hiring department along with the information provided in your employment application. Therefore, your answers must be consistent with your employment application information (especially in the "Education" and "Work Experience" sections), must be unambiguous, and must contain sufficient but concise detail and organization. A resume will not be accepted in lieu of completing this Supplemental Questionnaire. Lack of clarity, incomplete or inconsistent information, and/or disorganized presentation may negatively affect the hiring department's review of your Supplemental Questionnaire. I understand and agree to the above instructions.
- Yes
05
This role requires coordination with internal and external stakeholders. Describe your experience providing effective communication and collaboration across departments and agencies.
06
Describe your experience with report writing and data analysis. Include methods of research, how the work was checked for accuracy, and how the work was presented.
07
Describe your experience handling confidential information and how you ensure security and professionalism.
08
TRAINING AND EXPERIENCE EXAMINATION : The following questions are the Training and Experience (T&E) Examination. In addition to the City of Sacramento employment application, applicants must complete and submit online responses to the T&E questions. This exam will evaluate the relevance, level, and progression of a candidate's education, training and experience. Therefore, your responses to the T&E Exam questions should be thorough and complete because the exam score will determine your ranking on the eligible list for this job. In accordance with the City of Sacramento's Racial and Gender Equity Action Plan (RGEAP), this examination contains non-binary names and pronouns. For additional information regarding the City's RGEAP, please copy and paste the following link into a web browser: understand and agree to the above instructions.
- Yes
09
Select the one option that best describes your experience assisting with analyzing and interpreting information for administrative and/or operational procedural recommendations.
- Four years or more
- At least three years, but less than four years
- At least two years, but less than three years
- At least one year, but less than two years
- Less than one year
10
Select all the boxes that best describe the software programs you are proficient in and use on a regular basis in the administration of your job and/or education.
- Microsoft Outlook or equivalent
- Microsoft Word or equivalent
- Microsoft Excel or equivalent
- Microsoft PowerPoint or equivalent
- Microsoft Access or equivalent
- Microsoft Visio or equivalent
- Adobe Acrobat Professional
- ERP/HRIS software
- Applicant Tracking System software
- Accounting software
- None of the above
11
Select the one option that best describes your experience writing comprehensive reports which included your recommendation based on supportive information or data.
- Four years or more
- At least three years, but less than four years
- At least two years, but less than three years
- At least one year, but less than two years
- Less than one year
12
Select the one option that best describes your experience performing research and conducting surveys for potential solutions to administrative and/or operational issues or concerns.
- Four years or more
- At least three years, but less than four years
- At least two years, but less than three years
- At least one year, but less than two years
- Less than one year
13
Select the one option that best describes your experience establishing and maintaining effective working relationships with leadership, colleagues, and stakeholders to move new procedures or objectives forward.
- Four years or more
- At least three years, but less than four years
- At least two years, but less than three years
- At least one year, but less than two years
- Less than one year
Required Question
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0
Senior Cybersecurity Standards Professional
98073 Snoqualmie, Washington
Microsoft Corporation
Posted 5 days ago
Job Viewed
Job Description
At Microsoft, security is our top priority. Our services and products are considered critical infrastructure, and we are entrusted to protect the data of our customers around the world. Both the global cybersecurity threat landscape and regulatory landscape are rapidly changing, and to meet the challenge, we must continuously evolve to protect our products and services, as well as meet regulatory requirements.
**The Senior Cybersecurity Standards Professional** sits within the Corporate Standards Group (CSG), a global organization reporting out of Microsoft's headquarters in Redmond, WA in the United States. The role is part of a globally distributed team comprised of standards, certification, and other technical professionals. CSG partners closely with engineering and business groups, policy, legal and government affairs teams, and others as appropriate to drive standards and certification-related outcomes supporting Microsoft's business.
**The role**
Cybersecurity expertise is highly valued, including knowledge of current and emerging cybersecurity technologies, trends and techniques. We value familiarity with Microsoft technology, our customers' and partners' needs, and the regulatory landscape related to cybersecurity.
The person in this role will engage with international standards organizations as well as other multi-stakeholder, consensus-driven groups focused on cybersecurity. They will effectively represent Microsoft with clarity, credibility and leadership on a complex set of issues with a wide range of geographically distributed stakeholders, both internally and externally. They will also engage in public policy, intellectual property, and business strategy. The role requires working in a cross-domain fashion, across areas such as privacy, AI, data and platforms. They will be expected to establish a network across Microsoft to ensure that standards are developed to align to and meet the needs of the business.
Microsoft's mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can thrive at work and beyond.
**Responsibilities**
+ Develop cybersecurity standards and strategies that align to and meet the needs of the business, including regulatory considerations.
+ Execute defined strategies through deep engagement in diverse technical, policy and standards-focused organizations such as:
+ International Organization for Standardization (ISO)
+ International Electrotechnical Commission (IEC)
+ National Institute of Standards and Technology (NIST)
+ Create technical contributions to cybersecurity standards.
+ Effectively represent Microsoft at both the technical and governance level of the relevant organizations and constructively contributes to specifications under consideration by those bodies.
+ Maintain effective and collaborative relationships with other participants and leaders within the organizations in which Microsoft participates.
+ Work with industry partners, government bodies, enterprise customers, civil society, and academics to find common ground and opportunities for collaboration in the development and implementation of cybersecurity standards.
+ Work across technical domains to ensure that cybersecurity standards include measures to efficiently protect across services, data uses and technologies.
+ Facilitate alignment and collaboration with intra-group and/or cross-group projects and encourage accountability through project management approaches.
+ Collaborate with internal stakeholders (legal, policy, engineering teams) to understand and align objectives, priorities, and resources aroundcybersecurity standards strategy, including key policy and technical issues.
+ Work with product groups/engineering groups/feature groups to drive new content into standards and to provide awareness where standards are being developed for compliance purposes.
+ Embody our culture and values
**Qualifications**
**Required/Minimum Qualifications**
+ Bachelor's Degree in Computer Science, Cybersecurity or Engineering or related field AND 4+ years work experience in cybersecurity engineering, product or technical program management of cybersecurity domain, technical sales or relevant cybersecurity subject matter.
+ OR equivalent experience
+ 4+ years experience implementing, developing, or using cybersecurity technologies and techniques.
**Additional or Preferred Qualifications**
+ Experience implementing, developing, or using the following cybersecurity technologies and techniques:
+ Threat modelling
+ Red teaming
+ Network security operations
+ Secure software development
+ Supply chain security
+ Identity management
+ Encryption and key management
+ Incident management
+ Threat and vulnerability management
+ Experience implementing, using, or developing cybersecurity standards and/or regulations and requirements (e.g., ISO/IEC 27001/02, NIST Special Publication 800-53, Sarbanes-Oxley (SOX), Health Insurance Portability and Accountability Act (HIPPA), etc.)
+ Experience with cybersecurity in emerging technologies (e.g., AI).
+ Experience managing open-source security risks.
+ Technical experience in Information and Communication technology (ICT), including how complex software systems are built, deployed and used; and programming experience in online and distributed systems.
+ Experience in standards setting (or similar consensus-driven processes), including technical engagement activities with diverse stakeholders.
+ Experience in audit, certification, and conformity assessment such as SOX, ISO/IEC 27001, NIST 800-53, HIPPA, etc.
+ Expertise in other areas of technical regulation such as privacy, artificial intelligence, data flow and distributed systems.
Government Affairs IC4 - The typical base pay range for this role across the U.S. is USD $105,800 - $04,000 per year. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD 136,200 - 223,300 per year.
Certain roles may be eligible for benefits and other compensation. Find additional benefits and pay information here: will accept applications for the role until August 28th, 2025.
#CELA
Microsoft is an equal opportunity employer. Consistent with applicable law, all qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, color, family or medical care leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable local laws, regulations and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application process, read more about requesting accommodations ( .
**The Senior Cybersecurity Standards Professional** sits within the Corporate Standards Group (CSG), a global organization reporting out of Microsoft's headquarters in Redmond, WA in the United States. The role is part of a globally distributed team comprised of standards, certification, and other technical professionals. CSG partners closely with engineering and business groups, policy, legal and government affairs teams, and others as appropriate to drive standards and certification-related outcomes supporting Microsoft's business.
**The role**
Cybersecurity expertise is highly valued, including knowledge of current and emerging cybersecurity technologies, trends and techniques. We value familiarity with Microsoft technology, our customers' and partners' needs, and the regulatory landscape related to cybersecurity.
The person in this role will engage with international standards organizations as well as other multi-stakeholder, consensus-driven groups focused on cybersecurity. They will effectively represent Microsoft with clarity, credibility and leadership on a complex set of issues with a wide range of geographically distributed stakeholders, both internally and externally. They will also engage in public policy, intellectual property, and business strategy. The role requires working in a cross-domain fashion, across areas such as privacy, AI, data and platforms. They will be expected to establish a network across Microsoft to ensure that standards are developed to align to and meet the needs of the business.
Microsoft's mission is to empower every person and every organization on the planet to achieve more. As employees we come together with a growth mindset, innovate to empower others, and collaborate to realize our shared goals. Each day we build on our values of respect, integrity, and accountability to create a culture of inclusion where everyone can thrive at work and beyond.
**Responsibilities**
+ Develop cybersecurity standards and strategies that align to and meet the needs of the business, including regulatory considerations.
+ Execute defined strategies through deep engagement in diverse technical, policy and standards-focused organizations such as:
+ International Organization for Standardization (ISO)
+ International Electrotechnical Commission (IEC)
+ National Institute of Standards and Technology (NIST)
+ Create technical contributions to cybersecurity standards.
+ Effectively represent Microsoft at both the technical and governance level of the relevant organizations and constructively contributes to specifications under consideration by those bodies.
+ Maintain effective and collaborative relationships with other participants and leaders within the organizations in which Microsoft participates.
+ Work with industry partners, government bodies, enterprise customers, civil society, and academics to find common ground and opportunities for collaboration in the development and implementation of cybersecurity standards.
+ Work across technical domains to ensure that cybersecurity standards include measures to efficiently protect across services, data uses and technologies.
+ Facilitate alignment and collaboration with intra-group and/or cross-group projects and encourage accountability through project management approaches.
+ Collaborate with internal stakeholders (legal, policy, engineering teams) to understand and align objectives, priorities, and resources aroundcybersecurity standards strategy, including key policy and technical issues.
+ Work with product groups/engineering groups/feature groups to drive new content into standards and to provide awareness where standards are being developed for compliance purposes.
+ Embody our culture and values
**Qualifications**
**Required/Minimum Qualifications**
+ Bachelor's Degree in Computer Science, Cybersecurity or Engineering or related field AND 4+ years work experience in cybersecurity engineering, product or technical program management of cybersecurity domain, technical sales or relevant cybersecurity subject matter.
+ OR equivalent experience
+ 4+ years experience implementing, developing, or using cybersecurity technologies and techniques.
**Additional or Preferred Qualifications**
+ Experience implementing, developing, or using the following cybersecurity technologies and techniques:
+ Threat modelling
+ Red teaming
+ Network security operations
+ Secure software development
+ Supply chain security
+ Identity management
+ Encryption and key management
+ Incident management
+ Threat and vulnerability management
+ Experience implementing, using, or developing cybersecurity standards and/or regulations and requirements (e.g., ISO/IEC 27001/02, NIST Special Publication 800-53, Sarbanes-Oxley (SOX), Health Insurance Portability and Accountability Act (HIPPA), etc.)
+ Experience with cybersecurity in emerging technologies (e.g., AI).
+ Experience managing open-source security risks.
+ Technical experience in Information and Communication technology (ICT), including how complex software systems are built, deployed and used; and programming experience in online and distributed systems.
+ Experience in standards setting (or similar consensus-driven processes), including technical engagement activities with diverse stakeholders.
+ Experience in audit, certification, and conformity assessment such as SOX, ISO/IEC 27001, NIST 800-53, HIPPA, etc.
+ Expertise in other areas of technical regulation such as privacy, artificial intelligence, data flow and distributed systems.
Government Affairs IC4 - The typical base pay range for this role across the U.S. is USD $105,800 - $04,000 per year. There is a different range applicable to specific work locations, within the San Francisco Bay area and New York City metropolitan area, and the base pay range for this role in those locations is USD 136,200 - 223,300 per year.
Certain roles may be eligible for benefits and other compensation. Find additional benefits and pay information here: will accept applications for the role until August 28th, 2025.
#CELA
Microsoft is an equal opportunity employer. Consistent with applicable law, all qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, color, family or medical care leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable local laws, regulations and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application process, read more about requesting accommodations ( .
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1
Quality Assurance & Regulatory Affairs Manager
85718 Tucson, Arizona
Spectrum Plastics Group
Posted 21 days ago
Job Viewed
Job Description
Job Details
Job Location
Xeridiem - Tucson - Tucson, AZ
Description:
JOB PURPOSE:
Coordinate the development and administration of the company's quality assurance (QA) and regulatory affairs (RA) throughout the organization, in accordance with customer, company and regulatory requirements. Responsible for establishing quality assurance policies and procedures as they relate to ISO 13485:2016 and FDA 21 CFR Part 820 and other related regulations. This position is accountable for managing, planning, organizing, directing, and controlling a Quality Assurance Program which includes quality control, quality engineering, and product safety functions to ensure customer requirements are satisfied. The position must provide management controls and ensure regulatory compliance requirements are met for all products produced at Xeridiem and maintain the quality system to ensure compliance.
ESSENTIAL DUTIES:
•Serve as site Management Representative, ensuring the QMS complies with all Serve as site Management Representative, ensuring the QMS complies with all applicable standards and fostering a quality-focused culture.
•Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and global regulatory expectations.
•Direct internal and external audits (FDA, ISO, customer, notified body), manage responses to findings, and drive CAPA closure and systemic improvements.
•Oversee all QMS subsystems including document control, change management, nonconformance handling, training, supplier quality, and product release.
•Drive continuous improvement initiatives, leveraging tools such as FMEA, Root Cause Analysis, SPC, Lean/Six Sigma, and Kaizen to enhance product quality and operational performance.
•Lead efforts to identify and reduce Cost of Poor Quality (COPQ) through proactive risk identification, process standardization, scrap reduction and preventive action.
•Implement or enhance quality automation and digital transformation initiatives across QMS functions to increase process efficiency and data visibility.
•Monitor and report on key performance indicators (KPIs), quality trends, and management review data to inform leadership decisions.
•Provide quality oversight for new product development, validations, and design transfer to manufacturing, ensuring quality and regulatory integration from concept through commercialization.
•Oversee supplier qualification, performance monitoring, and resolution of supplier-related quality issues through effective collaboration and audit programs.
•Supervise, mentor, and develop a team of quality engineers, inspectors, and specialists, including goal setting, coaching, and performance management.
•Act as the site's Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR 2017/745 and internal policy.
•Provide regulatory strategies and guidance to cross-functional teams throughout the product lifecycle, including design control, labeling, and post-market activities.
•Prepare, review, and submit domestic and international regulatory submissions (e.g., 510(k), CE Technical Files, renewals, amendments).
•Maintain and update technical documentation, registrations, and licenses to ensure regulatory compliance for all commercialized products.
•Interface with regulatory authorities, including the FDA, Notified Bodies, and other global agencies, to support product submissions, inspection readiness, and response coordination.
•Monitor and communicate changes in global regulatory requirements, standards, and guidance documents; implement updates to internal procedures and documentation accordingly.
•Support post-market surveillance activities, including adverse event reporting, complaint trending, and field action documentation.
Position Requirements:
QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
•Bachelor's degree in scientific or engineering discipline (e.g., biomedical, mechanical, chemical, industrial engineering); equivalent experience considered.
•Minimum 5-7 years of experience in Quality Assurance leadership in a regulated industry, with experience managing Regulatory Affairs.
•Minimum 2 years of people management or supervisory experience, including direct reports, mentoring, and team development.
•Deep understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with global regulatory frameworks and submission processes.
•Demonstrated success in managing audits, Inspections, CAPA systems, product quality investigations, and QMS improvements.
•Experience with electronic QMS (eQMS) platforms and document management systems.
•Proficient in Microsoft Office Suite and quality/regulatory systems; skilled in data analysis, reporting, and dashboard development.
•Strong communication, leadership, and cross-functional collaboration skills.
•Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.
Preferred:
•Certifications such as RAC, CQE, CQA, CMQ/OE, or Six Sigma Green/Black Belt.
•Experience leading continuous improvement, COPQ reduction, and quality automation or digital transformation initiatives.
•Prior success in global regulatory submissions and product launch support, especially for Class II/III medical devices or combination products.
•Familiarity with Lean Manufacturing and operational excellence methodologies.
WORKING CONDITIONS:
Works under general supervision. Light physical activity with the majority of time spent standing and working on manufacturing line where protective clothing is required. Position requires flexible hours and ability to work around chemicals.
Job Location
Xeridiem - Tucson - Tucson, AZ
Description:
JOB PURPOSE:
Coordinate the development and administration of the company's quality assurance (QA) and regulatory affairs (RA) throughout the organization, in accordance with customer, company and regulatory requirements. Responsible for establishing quality assurance policies and procedures as they relate to ISO 13485:2016 and FDA 21 CFR Part 820 and other related regulations. This position is accountable for managing, planning, organizing, directing, and controlling a Quality Assurance Program which includes quality control, quality engineering, and product safety functions to ensure customer requirements are satisfied. The position must provide management controls and ensure regulatory compliance requirements are met for all products produced at Xeridiem and maintain the quality system to ensure compliance.
ESSENTIAL DUTIES:
•Serve as site Management Representative, ensuring the QMS complies with all Serve as site Management Representative, ensuring the QMS complies with all applicable standards and fostering a quality-focused culture.
•Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and global regulatory expectations.
•Direct internal and external audits (FDA, ISO, customer, notified body), manage responses to findings, and drive CAPA closure and systemic improvements.
•Oversee all QMS subsystems including document control, change management, nonconformance handling, training, supplier quality, and product release.
•Drive continuous improvement initiatives, leveraging tools such as FMEA, Root Cause Analysis, SPC, Lean/Six Sigma, and Kaizen to enhance product quality and operational performance.
•Lead efforts to identify and reduce Cost of Poor Quality (COPQ) through proactive risk identification, process standardization, scrap reduction and preventive action.
•Implement or enhance quality automation and digital transformation initiatives across QMS functions to increase process efficiency and data visibility.
•Monitor and report on key performance indicators (KPIs), quality trends, and management review data to inform leadership decisions.
•Provide quality oversight for new product development, validations, and design transfer to manufacturing, ensuring quality and regulatory integration from concept through commercialization.
•Oversee supplier qualification, performance monitoring, and resolution of supplier-related quality issues through effective collaboration and audit programs.
•Supervise, mentor, and develop a team of quality engineers, inspectors, and specialists, including goal setting, coaching, and performance management.
•Act as the site's Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR 2017/745 and internal policy.
•Provide regulatory strategies and guidance to cross-functional teams throughout the product lifecycle, including design control, labeling, and post-market activities.
•Prepare, review, and submit domestic and international regulatory submissions (e.g., 510(k), CE Technical Files, renewals, amendments).
•Maintain and update technical documentation, registrations, and licenses to ensure regulatory compliance for all commercialized products.
•Interface with regulatory authorities, including the FDA, Notified Bodies, and other global agencies, to support product submissions, inspection readiness, and response coordination.
•Monitor and communicate changes in global regulatory requirements, standards, and guidance documents; implement updates to internal procedures and documentation accordingly.
•Support post-market surveillance activities, including adverse event reporting, complaint trending, and field action documentation.
Position Requirements:
QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
•Bachelor's degree in scientific or engineering discipline (e.g., biomedical, mechanical, chemical, industrial engineering); equivalent experience considered.
•Minimum 5-7 years of experience in Quality Assurance leadership in a regulated industry, with experience managing Regulatory Affairs.
•Minimum 2 years of people management or supervisory experience, including direct reports, mentoring, and team development.
•Deep understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with global regulatory frameworks and submission processes.
•Demonstrated success in managing audits, Inspections, CAPA systems, product quality investigations, and QMS improvements.
•Experience with electronic QMS (eQMS) platforms and document management systems.
•Proficient in Microsoft Office Suite and quality/regulatory systems; skilled in data analysis, reporting, and dashboard development.
•Strong communication, leadership, and cross-functional collaboration skills.
•Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.
Preferred:
•Certifications such as RAC, CQE, CQA, CMQ/OE, or Six Sigma Green/Black Belt.
•Experience leading continuous improvement, COPQ reduction, and quality automation or digital transformation initiatives.
•Prior success in global regulatory submissions and product launch support, especially for Class II/III medical devices or combination products.
•Familiarity with Lean Manufacturing and operational excellence methodologies.
WORKING CONDITIONS:
Works under general supervision. Light physical activity with the majority of time spent standing and working on manufacturing line where protective clothing is required. Position requires flexible hours and ability to work around chemicals.
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2
Director, Quality Assurance and Regulatory Affairs
95199 San Jose, California
Noah Medical
Posted today
Job Viewed
Job Description
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.
A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
About You
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
California Pay Range
$201,000-$251,000 USD
Benefits & Perks (For Full Time Employees):
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.
A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
- Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
- Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect.
- Manages the RA/QA department functions through direct reports or subordinates.
- Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations.
- Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.
- Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
- Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.
- Serves as the designated Management Representative.
About You
- Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.
- Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
- Minimum of 3 years of supervisory experience of multiple exempt level employees.
- Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
- Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
- Experienced in conducting internal and supplier audits and hosting 3rd party audits.
- Must be a self-starter, team builder, and excellent in verbal and written communication.
- Preferred: Knowledge of sterile/disposable medical device production processes.
- Preferred: Master Degree, MBA, experienced with Software Validation,
- Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
California Pay Range
$201,000-$251,000 USD
Benefits & Perks (For Full Time Employees):
- Competitive Salary
- Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
- Equity & Bonus Program
- Life Insurance (company paid & supplemental) and Disability insurance
- Mental health support through medical insurance programs
- Legal and Pet Insurance
- 12+ paid holidays, 15-20 days of PTO + sick time
- Paid parental leave
- In-office snacks and beverages
- In-office lunch stipend
- Learning & Development Opportunities: On-demand online training and book reimbursement
- Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
View Now
3
Director, Quality Assurance and Regulatory Affairs
95111 San Jose, California
Noah Medical
Posted 6 days ago
Job Viewed
Job Description
Who We Are
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.
A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
* Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
* Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect.
* Manages the RA/QA department functions through direct reports or subordinates.
* Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations.
* Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.
* Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
* Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.
* Serves as the designated Management Representative.
About You
* Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.
* Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
* Minimum of 3 years of supervisory experience of multiple exempt level employees.
* Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
* Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
* Experienced in conducting internal and supplier audits and hosting 3rd party audits.
* Must be a self-starter, team builder, and excellent in verbal and written communication.
* Preferred: Knowledge of sterile/disposable medical device production processes.
* Preferred: Master Degree, MBA, experienced with Software Validation,
* Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
California Pay Range
$201,000 - $251,000 USD
Benefits & Perks (For Full Time Employees):
* Competitive Salary
* Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
* Equity & Bonus Program
* Life Insurance (company paid & supplemental) and Disability insurance
* Mental health support through medical insurance programs
* Legal and Pet Insurance
* 12+ paid holidays, 15-20 days of PTO + sick time
* Paid parental leave
* In-office snacks and beverages
* In-office lunch stipend
* Learning & Development Opportunities: On-demand online training and book reimbursement
* Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Create a Job Alert
Interested in building your career at Noah Medical? Get future opportunities sent straight to your email.
Create alert
Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery.
About The Team
The Director of RA/QA reports to the Head of Quality and Regulatory. This position is the day to day leader of the RA/QA function and provides guidance and leadership from a Regulatory and Quality perspective to the team throughout all stages of product development. We are looking for someone that is highly motivated in their career growth (possible vertical and horizontal growth to take on wider roles as well); must be a self-starter, team builder, and excellent in communication.
A Day In The Life Of Our Director, Quality Assurance and Regulatory Affairs at Noah Medical
* Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
* Involved in developing, modifying and executing RA/QA related company policies, which affect immediate operation(s) and may also have company-wide effect.
* Manages the RA/QA department functions through direct reports or subordinates.
* Regularly interacts with senior management of other functional areas, suppliers, and/or customers using soft skills to collaborate, think outside of the box, problem solve and gain acceptance of others in sensitive situations.
* Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.
* Coordinates the planning and organization of regulatory activities related to Design/Development/NPI, manufacturing, distribution control, and service
* Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.
* Serves as the designated Management Representative.
About You
* Requires a BS (preferably in Engineering or Technology) with a focus in Mechanical, Industrial, Manufacturing, Electrical, Life Sciences, etc.
* Minimum of 10 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
* Minimum of 3 years of supervisory experience of multiple exempt level employees.
* Experience working in a startup environment to meet rigorous timelines with NPI and product launch teams.
* Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.
* Experienced in conducting internal and supplier audits and hosting 3rd party audits.
* Must be a self-starter, team builder, and excellent in verbal and written communication.
* Preferred: Knowledge of sterile/disposable medical device production processes.
* Preferred: Master Degree, MBA, experienced with Software Validation,
* Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.
#LI-Hybrid
Pay Transparency
The Pay Range for this position is listed. Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.
California Pay Range
$201,000 - $251,000 USD
Benefits & Perks (For Full Time Employees):
* Competitive Salary
* Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
* Equity & Bonus Program
* Life Insurance (company paid & supplemental) and Disability insurance
* Mental health support through medical insurance programs
* Legal and Pet Insurance
* 12+ paid holidays, 15-20 days of PTO + sick time
* Paid parental leave
* In-office snacks and beverages
* In-office lunch stipend
* Learning & Development Opportunities: On-demand online training and book reimbursement
* Team building and company organized social and celebration events
Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.
Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.
Please visit our Careers Page to view our latest openings.
NO AGENCIES PLEASE - Please do not outreach to any managers or submit any resumes without a signed agreement from Talent Acquisition. Resumes shared with anyone at Noah Medical without a signed agreement will be considered your gift to us and no fee will be paid.
Create a Job Alert
Interested in building your career at Noah Medical? Get future opportunities sent straight to your email.
Create alert
View Now
4
Vice President, Regulatory Affairs & Quality Assurance
02173
Confidential
Posted 22 days ago
Job Viewed
Job Description
Vice President, Regulatory Affairs & Quality Assurance
About the Company
Innovative gene therapy company
Industry
Pharmaceuticals
Type
Public Company
Founded
2014
Employees
51-200
Categories
- Manufacturing
- Pharmaceuticals
- Medicine
- Chemical Products
- Biotechnology
Specialties
- gene therapy
- biotechnology
- adeno associated virus
- research
- parkinson's disease
- huntington's disease
- vector engineering
- sf9
- alzheimer's disease
- als
- amyotrophic lateral sclerosis
- friedrich's ataxia
- sod-1
- tauopathies
- neurology
- neuropharmacology
- and cns
About the Role
The Company is seeking a Vice President for Regulatory Affairs and Quality Assurance to provide strategic leadership in all regulatory and quality activities across preclinical, clinical, and manufacturing stages. The successful candidate will be responsible for devising and implementing regulatory strategies, ensuring compliance with GxP regulatory requirements, and fostering strong relationships with FDA and international regulatory authorities. This role requires the ability to proactively identify and mitigate regulatory and quality risks, as well as to provide innovative solutions in complex regulatory landscapes. The VP will also be tasked with leading a high-performing team, overseeing global regulatory submissions, and maintaining quality systems to support product approval.
Candidates for this position should have a BS degree in life sciences or a related area, with an advanced degree preferred, and a minimum of 10 years' experience in regulatory affairs strategy within the pharmaceutical industry. Specialized knowledge in drug development, product commercialization, and experience in neurology and gene therapy areas are also preferred. The role demands an enterprise leader with a proven track record in functional leadership, experience in writing and submitting regulatory INDs, and a strong background in global filing. The ideal candidate will have excellent communication, negotiation, and problem-solving skills, and the ability to influence and build cross-functional relationships.
Hiring Manager Title
Chief Medical Officer
Travel Percent
Less than 10%
Functions
- Medical Care/Hospital Administration
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5
Quality Assurance & Regulatory Affairs Compliance Specialist
33747 St. Petersburg, Florida
Catalent Pharma Solutions
Posted today
Job Viewed
Job Description
**Quality Assurance & Regulatory Affairs Compliance Specialist**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.
The **Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for quality and regulatory affairs services at the site level. The **Quality Assurance & Regulatory Affairs Compliance Specialist** will support the primary coordination of the Change Control processes for the site, also including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, and tracking and trending.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The position is 100% on-site at our St. Petersburg, FL location.
**The Role**
+ Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
+ Provide initial regulatory impact assessment on all change controls as required.
+ Liaise with customers to ensure customer requirements are satisfied.
+ Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
+ Prepare and submit all federal, state and local permits in a timely manner.
+ Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
+ Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution.
+ Perform other duties as assigned.
**The Candidate**
+ Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology) required.
+ A minimum of 3 years' related experience in the pharmaceutical manufacturing industry required.
+ Strong background working with Change Controls and management of change control processes required.
+ Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
+ Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
**Why You Should Join Catalent**
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ WellHub program to promote overall physical wellness.
+ 152 hours of PTO + 8 paid holidays.
+ Medical, dental and vision benefits effective day one of employment.
+ Defined career path and annual performance review and feedback process.
+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
+ Dynamic, fast-paced work environment.
+ Positive working environment focusing on continually improving processes to remain innovative.
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.
The **Quality Assurance & Regulatory Affairs Compliance Specialist** is responsible for quality and regulatory affairs services at the site level. The **Quality Assurance & Regulatory Affairs Compliance Specialist** will support the primary coordination of the Change Control processes for the site, also including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, and tracking and trending.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The position is 100% on-site at our St. Petersburg, FL location.
**The Role**
+ Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
+ Provide initial regulatory impact assessment on all change controls as required.
+ Liaise with customers to ensure customer requirements are satisfied.
+ Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
+ Prepare and submit all federal, state and local permits in a timely manner.
+ Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
+ Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution.
+ Perform other duties as assigned.
**The Candidate**
+ Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology) required.
+ A minimum of 3 years' related experience in the pharmaceutical manufacturing industry required.
+ Strong background working with Change Controls and management of change control processes required.
+ Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
+ Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
**Why You Should Join Catalent**
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ WellHub program to promote overall physical wellness.
+ 152 hours of PTO + 8 paid holidays.
+ Medical, dental and vision benefits effective day one of employment.
+ Defined career path and annual performance review and feedback process.
+ Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
+ Dynamic, fast-paced work environment.
+ Positive working environment focusing on continually improving processes to remain innovative.
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
View Now
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6
Quality Assurance & Regulatory Affairs Compliance Specialist
Florida, Florida
Catalent Inc
Posted 4 days ago
Job Viewed
Job Description
Quality Assurance & Regulatory Affairs Compliance Specialist
Position Summary
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates. Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges.
The Quality Assurance & Regulatory Affairs Compliance Specialist is responsible for quality and regulatory affairs services at the site level. The Quality Assurance & Regulatory Affairs Compliance Specialist will support the primary coordination of the Change Control processes for the site, also including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints, preparing annual product reviews, and tracking and trending.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The position is 100% on-site at our St. Petersburg, FL location.
The Role
-
Coordinate, Track, and Trend Change Controls issued for the facility. Ensuring change controls meet the initial requirements for implementation and reviewing completed change controls to ensure all actions have been appropriately completed.
-
Provide initial regulatory impact assessment on all change controls as required.
-
Liaise with customers to ensure customer requirements are satisfied.
-
Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required.
-
Prepare and submit all federal, state and local permits in a timely manner.
-
Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
-
Collaborates with Subject Matter Experts (SME)s, management and supervisory personnel from applicable areas to resolve problems affecting product quality; collaboration includes investigating and CAPA initiation, following up on issues and a working jointly towards resolution.
-
Perform other duties as assigned.
The Candidate
-
Bachelor's degree in science or related field required (Chemistry, Microbiology or Biology) required.
-
A minimum of 3 years' related experience in the pharmaceutical manufacturing industry required.
-
Strong background working with Change Controls and management of change control processes required.
-
Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred). PathWise Certification preferred.
-
Ability to solve problems with little guidance. Ability to identify the most efficient method to achieve predetermined objective. Ability to work effectively under pressure with constantly changing priorities and deadlines. Individuals may be required to sit, stand, walk regularly and occasionally lift to 15 lbs.; no lifting greater than 44.09 pounds without assistance. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Ability to work extended hours or off-hours as required.
Why You Should Join Catalent
-
Tuition Reimbursement - Let us help you finish your degree or earn a new one!
-
WellHub program to promote overall physical wellness.
-
152 hours of PTO + 8 paid holidays.
-
Medical, dental and vision benefits effective day one of employment.
-
Defined career path and annual performance review and feedback process.
-
Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.
-
Dynamic, fast-paced work environment.
-
Positive working environment focusing on continually improving processes to remain innovative.
-
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
-
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
View Now
7
Quality Assurance/Regulatory Affairs Specialist II
04072 Saco, Maine
Maine Molecular Quality Controls Inc
Posted 4 days ago
Job Viewed
Job Description
The Quality Assurance/Regulatory Affairs (QA/RA) Specialist II is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Under the supervision of the Manager of QA/RA, the QA/RA Specialist II is responsible for implementation, management, and maintenance of policies, procedures, and systems that ensure quality compliance to MMQCI's Quality System, based on federal Quality System Regulation 21CFR820. The successful candidate has a strong in vitro laboratory diagnostic industry background and is experienced in using and maintaining a Quality System according to 21CFR820. It is expected that the QA/RA Specialist II will rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us. We have found that our most effective collaboration and creative output stem from daily in-person interactions. As such, this role requires a full-time presence at our office in Saco, ME, and remote work is not an option for this position.
RESPONSIBILITIES:
- Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs). Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
- Reviews and approves validations of new equipment and processes.
- Assists or performs internal audits and supplier audits.
- Supports FDA and customer audits.
- Assembles Device Master Records for new products.
- Oversees training documentation of all MMQCI employees.
- Maintains MMQCI's ISO 13485 certification and prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
- Prepares and submits FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI's Class II products and maintains appropriate FDA registrations.
- Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development and Design Control, manufacturing, and/or marketing.
- Remains current on regulatory issues/trends affecting MMQCI products, assessing and communicating their impact to QA/RA colleagues and product development/support teams.
- Participates in, and may conduct, internal, customer, FDA, and ISO audits.
- Works closely with QA/ RA and other MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
- Provides training or presentations to cross-functional groups on a variety of regulatory topics.
- Writes SOPs and trains key personnel as needed.
- Perform other duties as assigned, including but not limited to, help monitor, maintain, and improve the quality system and serve as the person responsible for post-market surveillance, reporting and recalls.
- Must be a nonsmoker due to product contamination prevention requirements
- Bachelor of Science degree in Life Sciences
- 5+ years of employment in a cGMP regulated facility including current GMP regulations
- 2+ years of experience in Quality Assurance
- Excellent proof-reading skills
- Very detail oriented
- 2+years of experience with ISO 13485
- 2+ years of experience In Vitro Diagnostic Regulation (IVDR)
- Experience in laboratory medicine
- Good communication skills, written and oral
- Excellent computer skills including Excel
- Ability to multi-task in a dynamic environment with changing priorities
- Strong work ethic
- Ability to meet challenging timelines, in spite of obstacles
- Willingness to learn and pitch in as part of team
- Ability to communicate clearly and constructively to correct non-conforming behaviors and practices
- Medical insurance
- Dental insurance
- Vision Insurance
- 401(k)
- Profit sharing plan
- Vacation
- Holidays
- Sick leave
MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We're in a state-of-the-art facility + located in Saco, right next to the Eastern Trail. Come join us!
NO RECRUITERS PLEASE
View Now
8
VP, Regulatory Affairs & Quality Assurance (Boston)
02215 Boston, Massachusetts
Foundation Medicine
Posted 13 days ago
Job Viewed
Job Description
About the Job
The VP, Regulatory Affairs and Quality Assurance will be a key strategic member of the senior leadership team, responsible for overall management of Regulatory and Quality activities in support of Foundation Medicines growth objectives. In addition to their externally-facing activities, they will play an important role collaborating cross-functionally with Global Laboratory Operations, Product Development, Marketing, Manufacturing, Legal and certain strategic outside partners. The head of RA/QA will be a key leader in enhancing and developing the organizations RA/QA capabilities and qualifications to enable strategic initiatives.
Key Responsibilities
- Development, implementation, maintenance and overall success of the companys regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
- Building and managing relationships with FDA and global regulatory agencies and standards groups.
- Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
- Developing and maintaining current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions.
- Leads internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
- Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective.
- Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
- Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships.
- Ensure supplier quality objectives are met.
- Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
- Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality.
- Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements.
- Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
- Develop and manage department and study-specific budgets.
- Will be part of a Global Leadership Team and will need to collaborate effectively on broader initiatives.
Qualifications:
Basic Qualifications:
- Bachelors degree in relevant area of engineering or scientific discipline. Advanced degree (MS or PhD) is strongly preferred.
- Demonstrated and proven experience within their area of work and 15+ years of equivalent combined regulatory and quality professional experience.
- 10+ years of leadership experience of cross functional teams.
Preferred Qualifications:
- Advanced Degree in Law, Health Policy, Regulatory Affairs or Science
- Experience with in vitro diagnostics, laboratory-developed tests, diagnostics medical device products, and/or therapeutics development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality
- The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
- Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions (e.g., PMA, 510(k), CE Marking).
- Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation.
- 5+ years experience in Regulatory and Quality strategy development
- 5+ years experience in companion diagnostic work
- Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
- A commercial focus in the application of regulatory requirements.
- Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving.
- Strong conceptual, analytical, and problem-solving abilities.
- Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
- Understanding of HIPPA and importance of patient data privacy
- Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.
- Commitment to reflect FMIs values: passion, patients, innovation, and collaboration.
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9