6,383 Quality Standards jobs in the United States

Position: Housing Quality Standards Specialist

Supervisor: Program Enforcement Supervisor

Status: Non-Exempt

Summary: Under the direct supervision of a Program Enforcement Supervisor, the Housing Quality Standards Specialist will have the primary day-to-day responsibility of responding to and investigating alleged violations of rules, regulations, policies, procedures, inspection reports, HUD federal regulations by applicant, participants and owners for accuracy.

Essential Duties and Responsibilities: The below statements are intended to describe the general nature and scope of work performed under this position. This is not a complete listing of all responsibilities or skills required. Other duties may be assigned.

1. Track and investigate alleged violations of Program rules and regulations
2. Maintain records of compliance activities, including any complaints or investigations
3. Receive, log and investigate all Fraud Hotline complaints
4. Collaborates with other departments (e.g., Case Management, Operational Support, Office of Inspector General (OIG), etc.) and to the appropriate existing resources for investigation and resolution of program violations
5. Respond to alleged program violations of rules, regulations, policies, lease, and Statement of Understanding by evaluating or recommending the initiation of investigative procedures.
6. Review the HUD EIV income discrepancy for possible unreported income of participants and make recommendation for possible termination
7. Proactive reviews of regulatory policies and MDHCV administrative plan to stay informed of standards for the HCV program and Reasonable Accommodations
8. Proficiency in the use of all investigative tools, including, but not limited to (Criminal Justice Information System (CJIS), Driver and Vehicle Information Database System (DAVID), Accurint, National Crime Information Center (NCIC), Miami-Dade Clerk of Court records, etc.
9. Serve as back up for ADA Coordinator as necessary

BEHAVIORAL COMPETENCIES: To perform the job successfully, an individual should demonstrate the following competencies:

1. Leadership: Provide lead direction on special projects or processes by clearly and effectively setting course of action; and manage efficiency of processes, materials or programs by providing regular feedback and reinforcement to appropriate staff as required.
2. Performance Excellence: Set high standards of performance; pursue aggressive goals and work hard/smart to achieve them; strive for results and success; convey a sense of urgency and bring issues to closure; and persist despite obstacles and opposition.
3. Customer Service: Meet/exceed the expectations and requirements of internal and external customers; identify, understand, monitor and measure the needs of both internal and external customers; talk and act with customers in mind; and recognize working colleagues as customers.
4. Effective Communication: Ensure important information is passed to those who need to know; convey necessary information clearly and effectively orally or in writing; demonstrate attention to, and convey understanding of, the comments and questions of others; and listen effectively.
5. Quality: Demonstrate accuracy and thoroughness; look for ways to improve and promote quality; apply feedback to improve performance; monitor own work to ensure quality.
6. Responsiveness and Accountability: Demonstrate a high level of conscientiousness; hold oneself personally responsible for one's own work; and do the required fair share of work.
7. Integrity: Must abide by strict ethical standards, integrity, objectivity and confidentiality when dealing with client, employee or financial information, and budget analysis and must avoid any personal conflicts of interest.

Desired Qualifications : Education equivalent to a four-year degree from a regionally accredited institution in Public Administration, Social Science or a closely related field; a minimum of two years of progressively responsible work experience for a public agency, or related work in the social service or community service field preferred. Alternatively, a two-year degree with four years of experience will satisfy the qualifications. Must have the ability to interpret and apply regulations pertaining to the program. Must be able to communicate effectively both orally and in writing and have excellent interpersonal skills and possess strong computer and organizational skills.

Company Description

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.

Responsible for creating and maintaining standardization and oversight of all drug safety quality activities and for leading the development and implementation of continuous improvement initiatives to support the operational objectives of the global and regional drug safety organization. This individual is responsible for performing and managing quality activities in support of Drug Safety, including but not limited to: Audit/Inspection Readiness, PV Training, PV Deviation Investigation Management, Ad-hoc/Aggregate Report QC, ICSR QC,PV Project Management, PV Agreement Maintenance, and PV Documentation Management.

Job Description

KEY RESPONSIBILITIES

Quality (Quality, Compliance):

Ensure that GDSEC and MTDA DGS is in compliance with regulatory requirements and MTPC corporate policies and procedures and other applicable standards

Collaborate with affiliate safety departments, external departments within MTPG and business partners (e.g. CROs, Vendors, License Partners, Specialty Pharmacies) to ensure that MTDA drug safety and GDSEC activities are compliant with applicable global and/or local regulations

Design and implement continuous quality and productivity improvement processes with MTDA DGS and GDSEC senior management support

Collaborate across regions to ensure appropriate level of global standardization for GDSEC and MTDA DGS

Collaborate with MTPC Quality department on strategy and provide inspection-readiness support safety related audit and inspection

Determine FDA requirements for MTDA DGS activities and provide inspection-readiness support related to safety audit and inspection

Support MTPC Quality Management for drug safety audit and inspection

Work with MTDA DGS and GDSEC and appropriate affiliate safety offices to address audit findings

Implement all corrective actions from identification through resolution, for all valid deviations, identified by internal audits or regulatory inspections

Contribute to the development and maintenance of compliance tracking and reporting systems and tools

Develop and distribute compliance reports, as applicable

Anticipates potential regulatory or process impacts and collaborates with internal and external stakeholders to assess the risk and if applicable, facilitates implementation of remedial action(s).

Drives the periodic review and update of Safety Data Exchange Agreements with Business Partners.

Drives the periodic review and update of PV vendor procedures/agreements with PV-managed service providers.

Standards:

Lead the development and maintenance of Policies, SOP (Standard Operational Procedures) and WIN (Work Instructions) for all GDSEC and MTDA DGS functions

Lead review and revision of policies, SOPs, WINs for all MTPG global safety functions

Continually monitor and update procedures as necessary based on findings of audits/inspections, CAPA activities, regulatory changes, as necessary

Training:

Coordinate relevant MTDA DGS and GDSEC new hire training, functional training and all other relevant trainings

Manage MTDA DGS and GDSEC training records in collaboration with local Continuous Improvement Department personnel as appropriate

Develop and maintain relevant MTDA DGS and GDSEC training materials

Develop, manage and maintain training to all MTDA and MTPA employees on requirements for post-marketing adverse event reporting

Performs other departmental duties as assigned

Qualifications

Education:

Minimum Bachelor's degree in health care related field or other medical science degree combined with equivalent technical experience

Professional Experience:

Minimum of 8 - 10 years of pharmaceutical industry experience including clinical safety/pharmacovigilance and quality, standards, and training, and 2 years of management experience preferred

Minimum 5 years' experience of PV quality management (safety quality, compliance, internal audit experience, and project management)

Knowledge and Skills:

Strong interpersonal and communication skills with ability to collaborate effectively with other groups in a global matrix organization.

In-depth knowledge of pharmaceutical industry and knowledge of quality system regulations and policies

Good understanding of drug safety/pharmacovigilance duties, applicable international regulations and industry standards in pharmaceutical company, and working knowledge of EU / FDA regulations.

Good understanding of international guidelines, i.e. ICH/CIOMS, clinical development methodology and knowledge of clinical trial guidelines (e.g., GCP) and related regulation

Good knowledge of quality control/assurance, or regulatory assurance in a GCP environment

Excellent written and oral communication and interpersonal skills

Effective collaboration and communication with all various cultures, languages, work styles, and levels within the global organization

May require domestic and international travel

Additional Information

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

Overview

At SCA Health, we believe health care is about people – the patients we serve, the physicians we support and the teammates who push us forward. Behind every successful facility, procedure or innovation is a team of 15,000+ professionals working together, learning from each other and living out the mission, vision and values that define our organization.

As part of Optum, SCA Health is redefining specialty care by developing more accessible, patient-centered practice solutions for a network of more than 370 ambulatory surgical centers, over 400 specialty physician practice clinics and numerous labs and surgical hospitals. Our work spans a broad spectrum of services, all designed to support physicians, health systems and employers in delivering efficient, value-based care to patients without compromising quality or autonomy.

What sets SCA Health apart isn’t just what we do, it’s how we do it. Each decision we make is rooted in seven core values:

• Clinical quality

• Integrity

• Service excellence

• Teamwork

• Accountability

• Continuous improvement

• Inclusion

Our values aren’t empty words – they inform our attitudes, actions and culture. At SCA Health, your work directly impacts patients, physicians and communities. Here, you’ll find opportunities to build your career alongside a team that values your expertise, invests in your success, and shares a common mission to care for patients, serve physicians and improve health care in America.

At SCA Health, we offer a comprehensive benefits package to support your health, well-being, and financial future. Our offerings include medical, dental, and vision coverage, 401k plan with company match, paid time off, life and disability insurance, and more. Click here ( to learn more about our benefits.

Your ideas should inspire change. If you join our team, they will.

Responsibilities

We are actively recruiting for a Quality Standards Coordinator. This position will manage the following responsibilities.

A. Maintain knowledge of:

• Clinical best practices

• Accreditation and regulatory standards

• Quality improvement processes

• SCA Quality Standards Manual

• SCA Governing Body (GB) and Medical Executive Committee (MEC) Bylaws

• Center Medical Staff Rules & Regulations

• SCA policies and procedures

• Infection Control guidelines

• Nationally recognized patient safety goals (NPSG’s) for ASCs

• Environmental safety regulations and guidelines

• SCA Environment of Care (EOC) Manual

• SCA Medical Staff Services and Credentialing guidelines

• SCA Medical Staff Services and Credentialing Manual

• Center and regional education, orientation, and training programs

• ASC center leadership responsibilities

• SCA Homepages: Clinical Resources, Quality Standards, Environment of Care, Credentialing

B. Lead, facilitate, and advise the Center Quality Council and internal performance improvement teams:

• Set the agenda and maintain meeting minutes

• Ensure reporting of all mandatory and center specific monthly and quarterly reports for trends/areas for improvement to the Quality Council and Medical Executive Committee/Governing Body a minimum of quarterly:

• Medical Record Audit reports; Monthly or quarterly data collection from ongoing systematic chart review to assess quality of documentation.

• Infection Control reports

• Hospital Transfer/Complication reports

• Patient Safety; measurement of key measures of patient safety and hazard analysis/process redesign (adverse events, root cause analysis).

• Life safety (environment of care); Provide for a detailed assessment and evaluation of the Environment of Care (EOC) and the associated conditions, staff education and readiness and the various processes. Framework for the EOC includes the management processes and systems that affect safety, security, hazardous materials, emergency preparedness, life safety, medical equipment, and utilities management.

• Risk Management (incident reporting)

• Adverse Drug Reaction reports

• Cancellation logs

• Service Satisfaction reports (patients, staff and physicians)

• Center specific quality indicator reports as appropriate

• PI reports; Collection, analysis and summary of performance improvement data.

C. Provides strategic oversight of proactive and reactive patient safety activities:

• Root cause analysis.

• Clinical practice guidelines

• Sentinel Event Alerts

• Identification and data collection of center specific quality indicators based on high risk, problem prone procedures as appropriate.

• Review and revision of the PI Plan on an annual basis and preparation of the annual report of the PI program to the Medical Executive Committee/Governing Body.

• Documentation of all Performance Improvement activities and maintenance of records for a minimum of three years.

D. Provides strategic oversight of proactive and reactive patient safety activities (continued):

• Coordination of the center policies/procedures and processes to be in compliance with the current standards of applicable regulatory and accrediting agencies, and mandatory SCA Corporate policies.

• Working with the Administrator/designee to ensure currency of all physician files, medical staff appointments and/or privileges and compliance with credentialing policies and procedures. Coordinating as appropriate the peer review process and aggregate individual peer review data for presentation and review by the Medical Executive Committee and Governing Body at reappointment.

• Working with the Administrator/designee to ensure currency and completeness of all human resource and education files for center employees and contract personnel.

E. Maintain Center Survey readiness

• Assess center compliance with accreditation standards and regulations in collaboration with leadership and staff.

• Identify areas of vulnerability and direct the development of strategies to enhance compliance.

• Provide the overall direction necessary to ensure that clinical services provided are evidence-based, in accordance with standards established through state and federal regulations and applicable accreditation standards, including the National Patient Safety Goals.

F. Communicate Effectively Throughout All Levels of the Organization

• Proactively educate and train the leadership and staff regarding regulatory issues, new statutes/guidelines, and safety/quality/performance improvement activities and their respective responsibilities in carrying out the performance improvement program.

• Maintain effective communication on current center activities related to Safety/Quality/PI and Accreditation and seek consultation as needed for support from the Regional Quality Coordinator or assigned Group Director.

Qualifications

• Hold a minimum of a High School Diploma or GED.

• Have prior work experience in healthcare.

• RN required.

• Possess excellent written and oral communication skills.

• Possess knowledge of standards, survey methodology and related tools and resources for regulatory and accreditation requirements.

USD $71,600.00/Yr. USD $95,000.00/Yr.

Overview

At SCA Health, we believe health care is about people - the patients we serve, the physicians we support and the teammates who push us forward. Behind every successful facility, procedure or innovation is a team of 15,000+ professionals working together, learning from each other and living out the mission, vision and values that define our organization.

As part of Optum, SCA Health is redefining specialty care by developing more accessible, patient-centered practice solutions for a network of more than 370 ambulatory surgical centers, over 400 specialty physician practice clinics and numerous labs and surgical hospitals. Our work spans a broad spectrum of services, all designed to support physicians, health systems and employers in delivering efficient, value-based care to patients without compromising quality or autonomy.

What sets SCA Health apart isn't just what we do, it's how we do it . Each decision we make is rooted in seven core values :

• Clinical quality
• Integrity
• Service excellence
• Teamwork
• Accountability
• Continuous improvement
• Inclusion

Our values aren't empty words - they inform our attitudes, actions and culture. At SCA Health, your work directly impacts patients, physicians and communities. Here, you'll find opportunities to build your career alongside a team that values your expertise, invests in your success, and shares a common mission to care for patients, serve physicians and improve health care in America.

At SCA Health, we offer a comprehensive benefits package to support your health, well-being, and financial future. Our offerings include medical, dental, and vision coverage, 401k plan with company match, paid time off, life and disability insurance, and more. Click here to learn more about our benefits.

Your ideas should inspire change. If you join our team, they will .

Responsibilities

We are actively recruiting for a Quality Standards Coordinator. This position will manage the following responsibilities.

A. Maintain knowledge of:

• Clinical best practices
• Accreditation and regulatory standards
• Quality improvement processes
• SCA Quality Standards Manual
• SCA Governing Body (GB) and Medical Executive Committee (MEC) Bylaws
• Center Medical Staff Rules & Regulations
• SCA policies and procedures
• Infection Control guidelines
• Nationally recognized patient safety goals (NPSG's) for ASCs
• Environmental safety regulations and guidelines
• SCA Environment of Care (EOC) Manual
• SCA Medical Staff Services and Credentialing guidelines
• SCA Medical Staff Services and Credentialing Manual
• Center and regional education, orientation, and training programs
• ASC center leadership responsibilities
• SCA Homepages: Clinical Resources, Quality Standards, Environment of Care, Credentialing

B. Lead, facilitate, and advise the Center Quality Council and internal performance improvement teams:

• Set the agenda and maintain meeting minutes
• Ensure reporting of all mandatory and center specific monthly and quarterly reports for trends/areas for improvement to the Quality Council and Medical Executive Committee/Governing Body a minimum of quarterly:
  • Medical Record Audit reports; Monthly or quarterly data collection from ongoing systematic chart review to assess quality of documentation.
  • Infection Control reports
  • Hospital Transfer/Complication reports
  • Patient Safety; measurement of key measures of patient safety and hazard analysis/process redesign (adverse events, root cause analysis).
  • Life safety (environment of care); Provide for a detailed assessment and evaluation of the Environment of Care (EOC) and the associated conditions, staff education and readiness and the various processes. Framework for the EOC includes the management processes and systems that affect safety, security, hazardous materials, emergency preparedness, life safety, medical equipment, and utilities management.
  • Risk Management (incident reporting)
  • Adverse Drug Reaction reports
  • Cancellation logs
  • Service Satisfaction reports (patients, staff and physicians)
  • Center specific quality indicator reports as appropriate
  • PI reports; Collection, analysis and summary of performance improvement data.

C. Provides strategic oversight of proactive and reactive patient safety activities:

• Root cause analysis.
• Clinical practice guidelines
• Sentinel Event Alerts
• Identification and data collection of center specific quality indicators based on high risk, problem prone procedures as appropriate.
• Review and revision of the PI Plan on an annual basis and preparation of the annual report of the PI program to the Medical Executive Committee/Governing Body.
• Documentation of all Performance Improvement activities and maintenance of records for a minimum of three years.

D. Provides strategic oversight of proactive and reactive patient safety activities (continued):

• Coordination of the center policies/procedures and processes to be in compliance with the current standards of applicable regulatory and accrediting agencies, and mandatory SCA Corporate policies.
• Working with the Administrator/designee to ensure currency of all physician files, medical staff appointments and/or privileges and compliance with credentialing policies and procedures. Coordinating as appropriate the peer review process and aggregate individual peer review data for presentation and review by the Medical Executive Committee and Governing Body at reappointment.
• Working with the Administrator/designee to ensure currency and completeness of all human resource and education files for center employees and contract personnel.

E. Maintain Center Survey readiness

• Assess center compliance with accreditation standards and regulations in collaboration with leadership and staff.
• Identify areas of vulnerability and direct the development of strategies to enhance compliance.
• Provide the overall direction necessary to ensure that clinical services provided are evidence-based, in accordance with standards established through state and federal regulations and applicable accreditation standards, including the National Patient Safety Goals.

F. Communicate Effectively Throughout All Levels of the Organization

• Proactively educate and train the leadership and staff regarding regulatory issues, new statutes/guidelines, and safety/quality/performance improvement activities and their respective responsibilities in carrying out the performance improvement program.
• Maintain effective communication on current center activities related to Safety/Quality/PI and Accreditation and seek consultation as needed for support from the Regional Quality Coordinator or assigned Group Director.

Qualifications

• Hold a minimum of a High School Diploma or GED.
• Have prior work experience in healthcare.
• RN required .
• Possess excellent written and oral communication skills.
• Possess knowledge of standards, survey methodology and related tools and resources for regulatory and accreditation requirements.

USD $71,600.00/Yr. USD $95,000.00/Yr.

Join our team as a strategic thinker in Regulatory Operations, part of Payment Operations, supporting global regulatory obligations. This complex role involves executing global regulatory reporting across all lines of businesses, managing changes driven by global regulators, product changes and automation agendas. We seek an Executive Director to lead our Quality & Standards team, ensuring compliance with evolving regulations.

As an Executive Director in Payments Regulatory Operations - Quality & Standards Lead, you will partner with Operations, Product, Technology, Audit, Compliance, Regulators, and many other groups to manage an ever-changing landscape. You will have the opportunity to think strategically and manage day-to-day issues at a granular level, shaping how we support the Firm's compliance to an increasingly complex regulatory landscape.

Job Responsibilities:

• Own and manage the Reporting Catalogue / Inventory
• Execute production testing and implement proactive quality analysis strategies
• Develop and establish Regional & Global standards
• Implement a quality framework (MEPs, incidents, Core) to prevent repeat errors
• Manage regulatory issues as they arise, addressing problems and challenges regularly
• Partner with Operations, Product, Technology, Audit, Compliance, Regulators, and other groups to navigate an ever-changing landscape
• Think strategically while managing day-to-day issues at a granular level

Required Qualifications, Capabilities and Skills:

• 5+ years of experience in Operations with direct experience in Payments
• Strong knowledge of controls and regulatory matters
• Proven track record of control uplift deliverables
• Proactive in identifying quality, standards, and control gaps, and addressing them ahead of a regulatory identifying them for us
• Partners well with other groups sat outside of the team's reporting line, excellent interpersonal skills
• Ability to communicate clearly and confidently across multiple aspects of the organization at all levels
• Logical, structured approach to planning, problem solving and decision-making
• Solid awareness of controls and risk management protocols
• Self-starter with ability to manage own workload and deliverables

Preferred Qualifications, Capabilities and Skills:

• Proficiency in Excel and ability to clearly storyboard using PowerPoint
• Awareness of controls and risk management protocols
• Knowledge of user tools such as JIRA, Lucid, Monday.com
• Experience of finding Artificial Intelligence solutions to solve Business problems

JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.

The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement.

A Typical Day in the Role Might Look Like:

* Plan and prioritize goals and projects aligned with the group's strategic vision.


* Manage team resources, including hiring strategies and candidate endorsements.


* Oversee staff management, including onboarding, performance reviews, and career development.


* Attend GDQGO Leadership Team meetings, contributing to strategy and quality metrics discussions.


* Lead process improvement initiatives and champion innovation for quality objectives.


* Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices.


* Integrate quality risk management in processes where applicable.


* Collaborate with other department leaders for effective quality oversight.


* Represent senior management at quality forums and during regulatory inspections.



This Role May Be for You If You:

* Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards.


* Can act as the primary Business Process Owner and Subject Matter Expert (SME) for the Quality Vault.


* Are experienced in implementing new Veeva Vault Quality features in collaboration with the GD IT team.


* Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development.


* Oversee quality data stewardship and support inspection and audit activities.


* Serve as an escalation point for significant Quality Vault issues to Executive Quality Leadership.


* Participate in the governance and oversight of system vendors, including issue management.


* Review and maintain CSV policies and artifacts, providing guidance on test failures.


* Oversee quality reviews and approvals for equipment qualification artifacts and testing results.


* Create and implement best practice quality strategies and policies with the GDQGO Leadership Team.


* Champion the Quality Management System and enhance awareness within Global Development.


* Lead governance activities and facilitate quality oversight forums.


* Ensure reporting of quality-related metrics to support continuous improvement.


* Oversee the Quality Event portfolio, providing SME guidance and support for root cause analysis and CAPA development.


* Collaborate with leaders to define Quality System Metrics (KQIs/KPIs) for measuring QMS health.



To be considered for this role, you must have a BS with 14+ years of relevant experience, MS preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$212,900.00 - $354,800.00

Job Details

The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement.

A Typical Day in the Role Might Look Like:

• Plan and prioritize goals and projects aligned with the group's strategic vision.
• Manage team resources, including hiring strategies and candidate endorsements.
• Oversee staff management, including onboarding, performance reviews, and career development.
• Attend GDQGO Leadership Team meetings, contributing to strategy and quality metrics discussions.
• Lead process improvement initiatives and champion innovation for quality objectives.
• Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices.
• Integrate quality risk management in processes where applicable.
• Collaborate with other department leaders for effective quality oversight.
• Represent senior management at quality forums and during regulatory inspections.

This Role May Be for You If You:

• Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards.
• Can act as the primary Business Process Owner and Subject Matter Expert (SME) for the Quality Vault.
• Are experienced in implementing new Veeva Vault Quality features in collaboration with the GD IT team.
• Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development.
• Oversee quality data stewardship and support inspection and audit activities.
• Serve as an escalation point for significant Quality Vault issues to Executive Quality Leadership.
• Participate in the governance and oversight of system vendors, including issue management.
• Review and maintain CSV policies and artifacts, providing guidance on test failures.
• Oversee quality reviews and approvals for equipment qualification artifacts and testing results.
• Create and implement best practice quality strategies and policies with the GDQGO Leadership Team.
• Champion the Quality Management System and enhance awareness within Global Development.
• Lead governance activities and facilitate quality oversight forums.
• Ensure reporting of quality-related metrics to support continuous improvement.
• Oversee the Quality Event portfolio, providing SME guidance and support for root cause analysis and CAPA development.
• Collaborate with leaders to define Quality System Metrics (KQIs/KPIs) for measuring QMS health.

To be considered for this role, you must have a BS with 14+ years of relevant experience, MS preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$212,900.00 - $354,800.00

Company

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Stock Symbol: REGN

Stock Exchange: NASDAQ

Company info
Website Phone Location Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement.

A Typical Day in the Role Might Look Like:

* Plan and prioritize goals and projects aligned with the group's strategic vision.


* Manage team resources, including hiring strategies and candidate endorsements.


* Oversee staff management, including onboarding, performance reviews, and career development.


* Attend GDQGO Leadership Team meetings, contributing to strategy and quality metrics discussions.


* Lead process improvement initiatives and champion innovation for quality objectives.


* Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices.


* Integrate quality risk management in processes where applicable.


* Collaborate with other department leaders for effective quality oversight.


* Represent senior management at quality forums and during regulatory inspections.



This Role May Be for You If You:

* Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards.


* Can act as the primary Business Process Owner and Subject Matter Expert (SME) for the Quality Vault.


* Are experienced in implementing new Veeva Vault Quality features in collaboration with the GD IT team.


* Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development.


* Oversee quality data stewardship and support inspection and audit activities.


* Serve as an escalation point for significant Quality Vault issues to Executive Quality Leadership.


* Participate in the governance and oversight of system vendors, including issue management.


* Review and maintain CSV policies and artifacts, providing guidance on test failures.


* Oversee quality reviews and approvals for equipment qualification artifacts and testing results.


* Create and implement best practice quality strategies and policies with the GDQGO Leadership Team.


* Champion the Quality Management System and enhance awareness within Global Development.


* Lead governance activities and facilitate quality oversight forums.


* Ensure reporting of quality-related metrics to support continuous improvement.


* Oversee the Quality Event portfolio, providing SME guidance and support for root cause analysis and CAPA development.


* Collaborate with leaders to define Quality System Metrics (KQIs/KPIs) for measuring QMS health.



To be considered for this role, you must have a BS with 14+ years of relevant experience, MS preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$212,900.00 - $354,800.00

Job Details

The Head, Global Development Quality Standards & Continuous Improvement (GDQSCI) will lead and support the GDQSCI sub-function, ensuring effective oversight of responsibilities and team management. As a member of the Global Development Quality Governance & Oversight (GDQGO) Leadership Team, this role involves overseeing the Global Development Quality Vault, ensuring robust Computer System Validation (CSV) and quality oversight for equipment and assay qualification activities, while promoting a culture of continuous improvement.

A Typical Day in the Role Might Look Like:

• Plan and prioritize goals and projects aligned with the group's strategic vision.
• Manage team resources, including hiring strategies and candidate endorsements.
• Oversee staff management, including onboarding, performance reviews, and career development.
• Attend GDQGO Leadership Team meetings, contributing to strategy and quality metrics discussions.
• Lead process improvement initiatives and champion innovation for quality objectives.
• Contribute to GDQ/GDQGO policies and ensure compliance with regulations and best practices.
• Integrate quality risk management in processes where applicable.
• Collaborate with other department leaders for effective quality oversight.
• Represent senior management at quality forums and during regulatory inspections.

This Role May Be for You If You:

• Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards.
• Can act as the primary Business Process Owner and Subject Matter Expert (SME) for the Quality Vault.
• Are experienced in implementing new Veeva Vault Quality features in collaboration with the GD IT team.
• Can assign super-users and SMEs for Quality Vault systems and lead operational and quality metrics development.
• Oversee quality data stewardship and support inspection and audit activities.
• Serve as an escalation point for significant Quality Vault issues to Executive Quality Leadership.
• Participate in the governance and oversight of system vendors, including issue management.
• Review and maintain CSV policies and artifacts, providing guidance on test failures.
• Oversee quality reviews and approvals for equipment qualification artifacts and testing results.
• Create and implement best practice quality strategies and policies with the GDQGO Leadership Team.
• Champion the Quality Management System and enhance awareness within Global Development.
• Lead governance activities and facilitate quality oversight forums.
• Ensure reporting of quality-related metrics to support continuous improvement.
• Oversee the Quality Event portfolio, providing SME guidance and support for root cause analysis and CAPA development.
• Collaborate with leaders to define Quality System Metrics (KQIs/KPIs) for measuring QMS health.

To be considered for this role, you must have a BS with 14+ years of relevant experience, MS preferred.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)
$212,900.00 - $354,800.00

Company

Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Stock Symbol: REGN

Stock Exchange: NASDAQ

Company info
Website Phone Location Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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