5,226 Director Of Qa jobs in the United States

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.
**Education / Experience**
+ Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
+ 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
+ Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
**What You Will Do:**
+ Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
+ Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
+ Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
+ Lead a Global Community of Practice for information sharing between sites.
+ Assist sites with data integrity risk assessments and mitigation/remediation plans.
+ Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
+ Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
+ Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
+ Develop training content that global and site training coordinators can deploy.
+ Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.
**Knowledge, Skills, Abilities**
+ Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
+ Experience with external surveillance and searching for latest information related to data integrity and quality culture.
+ Ability to evaluate and resolve complex technical problems by using network resources.
+ Ability to drive functional, technical, and operational excellence.
+ Work independently with little supervision, especially remotely.
+ Ability to develop an internal strategic network while working remotely.
+ Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
+ Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
**Physical Requirements**
+ This position requires ability to work with computer systems.
+ 25-50% domestic and/or international travel may be required.
+ Ability to clearly communicate verbally via Web-based conferencing platforms.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**RWE Clean Energy, LLC**
**To start as soon as possible, full time, permanent**
**Functional area:** Engineering
**Remuneration:** Exempt
RWE Clean Energy (RWE CE) will build between 2.5 GW and 4.5 GWs of renewable energy generation projects in the United States on an annual basis between 2024 and 2032. The **Senior Director of Quality Assurance and Quality Control (QA/QC)** shall be responsible to ensure that the appropriate QA/QC programs, procedures, and systems are in place to support the construction of renewable energy projects, including equipment (solar panels, WTGs, and HV equipment). This role will coordinate with other RWE CE teams (Preconstruction, Engineering, and Construction) to ensure that lessons learned are incorporated into new projects, and to the extent possible issues are raised ahead of time to avoid construction delays, rework, or low-quality work. Part of the lessons learned process shall included a systematic review of each project and a process to ensure that corrective actions are included in future designs or contract requirements.The core function of this position is to ensure that RWE CE constructs renewable energy facilities that are built per the specified requirements, projects are turned over to Operations fully functional, and in a state that they will achieve their availability goals on a continual basis.
**_Role Responsbilities:_**
+ Manage external contractors to provide QA/QC oversight on construction projects.
+ Responsible to manage, develop, and mentor the RWE CE QA/QC team so they can ensure that construction projects and equipment are delivered, installed and functional per the requirements.
+ Ensure that a QA/QC program is established for all renewable energy technologies, the QA/QC program is a contractual requirement in all construction contracts, the construction project is appropriately staffed with RWE CE or contracted staff, and that the QA/QC program is implemented, tracked, and non-conformance issues resolved while coordinating with the Project Execution Manager.
+ Establish and implement a formal lessons learned process and coordinate with the appropriate teams to ensure that corrective actions are in place to prevent future non-conformance issues.
+ Responsible to establish and implement a QA/QC program for RWE CE procured equipment to ensure equipment meets the required specifications. This shall include factory audits, factory inspections, factory acceptance testing (FAT) and other requirements per industry standards.
**_Job Requirements and Expereince:_**
+ Minimum of 10 years of experience in renewable energy construction and equipment QA/QC
+ 4-year degree in engineering or construction management prefered. However, actual experience in QA/QC work will be considered.
**Benefits offered:** Medical, Dental, Vision, Life Insurance, Short-Term Disability, Long-Term Disability, 401(k) match, Flexible Spending Accounts, EAP, Education Assistance, Parental Leave, Paid time off, and Holidays. Eligible employees also participate in short-term incentives, in addition to salary.
**Apply with just a few clicks:** ad code **91015**
Any questions? **Contact HR:**
We look forward to meeting you. Of course, you can find us on LinkedIn, Instagram, Facebook, YouTube and Xing, too.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
Through its subsidiary RWE Clean Energy, RWE is the third largest renewable energy company in the United States, with a presence in most U.S. states from coast to coast. RWE's team of about 2,000 employees in the U.S. stands ready to help meet the nation's growing energy needs. With its homegrown and fastest-to-market product, RWE supports the goal of American Energy dominance and independence. To that end, RWE Clean Energy is committed to increasing its already strong asset base of over 10 gigawatts of operating wind, solar and battery projects, focusing on providing high-quality jobs. RWE invests in local and rural communities while strengthening domestic manufacturing supporting the renaissance of American industry. This is complemented by RWE's energy trading business. RWE is also a major offtaker of American liquified natural gas (LNG).
As an energy company with a successful history spanning more than 125 years, RWE has an extensive knowledge of the energy markets and an excellent expertise in all major power generation and storage technologies, from nuclear, coal and gas to hydro, batteries, wind and solar.
Every project brings constantly-evolving technical, practical and social challenges - and drives a culture where everybody thrives, has fun and feels excited by each day. As the third largest renewable energy company in the U.S., you'll also have the freedom to act with conviction and courage as we pivot to new technologies - and continuously improve, together.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.
**Education / Experience**
+ Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
+ 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
+ Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
**What You Will Do:**
+ Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
+ Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
+ Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
+ Lead a Global Community of Practice for information sharing between sites.
+ Assist sites with data integrity risk assessments and mitigation/remediation plans.
+ Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
+ Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
+ Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
+ Develop training content that global and site training coordinators can deploy.
+ Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.
**Knowledge, Skills, Abilities**
+ Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
+ Experience with external surveillance and searching for latest information related to data integrity and quality culture.
+ Ability to evaluate and resolve complex technical problems by using network resources.
+ Ability to drive functional, technical, and operational excellence.
+ Work independently with little supervision, especially remotely.
+ Ability to develop an internal strategic network while working remotely.
+ Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
+ Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
**Physical Requirements**
+ This position requires ability to work with computer systems.
+ 25-50% domestic and/or international travel may be required.
+ Ability to clearly communicate verbally via Web-based conferencing platforms.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.
**Education / Experience**
+ Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
+ 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
+ Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
**What You Will Do:**
+ Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
+ Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
+ Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
+ Lead a Global Community of Practice for information sharing between sites.
+ Assist sites with data integrity risk assessments and mitigation/remediation plans.
+ Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
+ Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
+ Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
+ Develop training content that global and site training coordinators can deploy.
+ Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.
**Knowledge, Skills, Abilities**
+ Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
+ Experience with external surveillance and searching for latest information related to data integrity and quality culture.
+ Ability to evaluate and resolve complex technical problems by using network resources.
+ Ability to drive functional, technical, and operational excellence.
+ Work independently with little supervision, especially remotely.
+ Ability to develop an internal strategic network while working remotely.
+ Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
+ Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
**Physical Requirements**
+ This position requires ability to work with computer systems.
+ 25-50% domestic and/or international travel may be required.
+ Ability to clearly communicate verbally via Web-based conferencing platforms.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.
**Education / Experience**
+ Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
+ 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
+ Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
**What You Will Do:**
+ Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
+ Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
+ Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
+ Lead a Global Community of Practice for information sharing between sites.
+ Assist sites with data integrity risk assessments and mitigation/remediation plans.
+ Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
+ Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
+ Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
+ Develop training content that global and site training coordinators can deploy.
+ Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.
**Knowledge, Skills, Abilities**
+ Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
+ Experience with external surveillance and searching for latest information related to data integrity and quality culture.
+ Ability to evaluate and resolve complex technical problems by using network resources.
+ Ability to drive functional, technical, and operational excellence.
+ Work independently with little supervision, especially remotely.
+ Ability to develop an internal strategic network while working remotely.
+ Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
+ Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
**Physical Requirements**
+ This position requires ability to work with computer systems.
+ 25-50% domestic and/or international travel may be required.
+ Ability to clearly communicate verbally via Web-based conferencing platforms.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
**Job Description**
The QA Director, Global Data Integrity Program will own the Global DI Program that ensures compliance to regulatory requirements at all Pharmaceutical Services Group (PSG) sites. In addition to ensuring implementation at all sites, the candidate will drive practical improvements and will develop and monitor Key Performance Indicators to measure the effectiveness of the program.
**Education / Experience**
+ Bachelor's Degree or higher in Pharmacy, Engineering, Science or other applicable degree with relevant work experience.
+ 10 years plus experience in pharmaceutical manufacturing, or pharmaceutical laboratory testing with confirmed experience leading data integrity programs.
+ Proficient in the application of 21CFR Part 11, Annex 11 and other applicable regulations
**What You Will Do:**
+ Stay current on global regulations and expectations and industry trends related to data integrity. Update global policies and procedures and other program elements to maintain a state of regulatory compliance.
+ Help sites resolve challenges in program implementation, instrument/equipment remediation, etc.
+ Stay current with industry standard processes through benchmarking and active participation in industry groups such as PDA and ISPE.
+ Lead a Global Community of Practice for information sharing between sites.
+ Assist sites with data integrity risk assessments and mitigation/remediation plans.
+ Analyze metrics and address trends to Site Quality Heads and General Managers and Division Quality VPs.
+ Use PPI (Practical Process Improvement) methodology to develop or improve processes that enable sites to improve documentation and data integrity requirements.
+ Support sites in explaining the Data Integrity Program for regulatory and client audits as needed.
+ Develop training content that global and site training coordinators can deploy.
+ Take on other duties/projects as assigned to support the Global Quality Compliance Team as required.
**Knowledge, Skills, Abilities**
+ Proven ability to influence and lead professional multidisciplinary staff in order to achieve goals.
+ Experience with external surveillance and searching for latest information related to data integrity and quality culture.
+ Ability to evaluate and resolve complex technical problems by using network resources.
+ Ability to drive functional, technical, and operational excellence.
+ Work independently with little supervision, especially remotely.
+ Ability to develop an internal strategic network while working remotely.
+ Proficiency in Microsoft Office Suite (Teams, Word, Excel, PowerPoint, etc.).
+ Strong written and verbal communication skills and effective presentation skills with specific emphasis on upwards communication.
**Physical Requirements**
+ This position requires ability to work with computer systems.
+ 25-50% domestic and/or international travel may be required.
+ Ability to clearly communicate verbally via Web-based conferencing platforms.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $145,500.00-$218,250.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Job Responsibilities:**
+ Designs, develops and delivers high quality and high impact learning products, programs and services that provide functional, GMP and product knowledge for site staff to achieve a high level of performance in their jobs.
+ Works on projects that are cross-commercial in nature and that support the Product Operations, Quality and Compliance organizations at the manufacturing site.
+ Oversees budget and timelines.
+ Integrates knowledge of business and performance requirements into an effective learning strategy for new hires and incumbent staff curriculum.
+ Supports the execution of training deliverables throughout the design/development process and trainer certification.
+ Collaborates with the Senior Management team to ensure optimal tracking of training and development records.
+ Evaluates the effectiveness of trainings, implementing modifications when necessary, and monitoring training compliance for staff.
**Knowledge:**
+ Demonstrates understanding of training, instructional design, communication and/or education.
+ Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes and product transfer.
+ Demonstrates advanced level of functional expertise and process management to oversee the integrated design and development of training programs.
+ Demonstrates strong verbal, written, and interpersonal communication skills.
+ Demonstrates proficiency in Microsoft Office applications.
+ Has experience in setting up and managing e-learning modules - experience in instructional design.
**Specific Education & Experience Requirements:**
+ 7+ years of relevant experience and a BS or BA degree.
+ 5+ years of relevant experience and a MS degree.
+ Applied experience in designing/developing e-learning is preferred.
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

**Position Overview**
The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FUJIFILM Biotechnologies in TX. Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation. Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Ensure the site PQS sub-system is aligned with the harmonized global FUJIFILM Biotechnologies PQS, organizational goals and objectives, and areas of continuous improvement.
**Company Overview**
The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives.
From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.
If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki.
Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**_Primary Responsibilities:_**
+ Develop, implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
+ Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards, regulatory requirements, and partner commitments.
+ Lead the Quality Compliance team to deliver exceptional performance of each assigned sub-system.
+ Internal Audit.
+ External (Customer) Audit.
+ Health Auditory Inspection & Remediation.
+ Liaise with internal and external stakeholders to achieve expected business outcomes.
+ Partner with Quality Compliance to ensure the site is inspection ready at all times.
+ Implement audit/inspection learnings within the site QMS; share learnings between FDB sites.
+ Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
+ Provide expert guidance and interpretation on regulatory requirements.
+ Recruit, hire, and manage the team in line with FDBT policies and practices.
+ Ability to serve as deputy for Senior Director Quality Systems.
+ Any other duties as assigned.
**_Qualifications:_**
+ Bachelor's degree with 10+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR,
+ Associate's degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
+ 6+ years of experience in a supervisory or managerial role.
+ 5+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
+ Experience with biologics - vaccines, gene therapy, mAb, etc., preferred.
+ Experience within CDMO preferred.
+ Advanced Degree preferred.
+ ASQ Certification preferred.
+ Expert understanding of Pharmaceutical Quality Systems.
+ Excellent written and oral communication skills.
+ Excellent organizational, analytical, data review and report writing skills.
+ Ability to set personal performance goals and provide input to departmental objectives.
+ Develop staff to maximize contributions to the team and the company.
+ Ability to multitask and easily prioritize work.
+ Ability to work independently with little supervision.
+ Proficient in Microsoft Excel, Word and PowerPoint.
+ All candidates must have a working knowledge of CGMP regulations for the production of drug substance, drug product, biologics, vaccine, and/or advanced therapy products.
**_Working Conditions & Physical Requirements:_**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
+ Experience prolonged standing, some bending, stooping, and stretching.
+ Ability to sit for long periods to work on a computer.
+ Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
+ Lifting up to 25 pounds on occasion.
+ Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
+ Must be willing to work flexible hours.
+ Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
+ Must be willing to travel occasionally, as needed.
+ Attendance is mandatory.
_To all agencies: Please, no phone calls or emails to any_ _employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( or ).
**Job Locations** _US-TX-College Station_
**Posted Date** _2 months ago_ _(8/15/2025 1:20 PM)_
**_Requisition ID_** _ _
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

**Position Overview**
**Director, QA Drug Substance Operations**
Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations.
In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams.
As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment.
**Company Overview**
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**What You'll Do**
+ Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance ofpersonnel to foster a high-performing team environment
+ Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements
+ Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards
+ Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation
+ Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary
+ Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements
+ Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle
+ Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed
+ Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards
+ Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications,traceability matrices, qualification protocols, validation plans, and validation summary reports
+ Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness
+ Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities
+ Acts as a key advocate for quality excellence across all levels of the organization
+ Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility
+ Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement.
+ Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network
+ Actively participates in cross-functional initiatives to align global quality strategies
+ Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations
+ Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments
+ Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines
+ Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management
+ Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success
+ Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies
+ Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities
+ Performs other duties, as assigned
**Minimum Requirements:**
- Bachelor's degree in engineering, life sciences with 13+ years of related experience OR
- Master's degree in engineering, life sciences with 11+ years of related experience OR
- Ph.D. in engineering, life sciences with 9+ years of related experience
- 10+ years of people management, leadership, and team management experience
- Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.
- Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.
- Experience collaborating and interacting with a global team.
- Training and/or familiarity with Quality Risk Management principles
**Preferred Requirements:**
- 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility
- Experience in other GMP functions (manufacturing, MSAT, Engineering)
- Strong track record of driving operational excellence
- Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade
**Physical and Work Environment Requirements:**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes
Ability to sit for prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _4 months ago_ _(5/29/ :48 PM)_
**_Requisition ID_** _ _
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_