MQA Manufacturing Technical Lead

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those who rely on our products.

What You Will Achieve

Manufacturing Quality Assurance (MQA) Manufacturing Technical Lead - Train 1, 2, 1/2Chem, Vx Core is responsible for providing strategic leadership and oversight of Quality Assurance support for manufacturing operations. This role ensures compliance with GMP requirements, regulatory expectations, and internal quality standards while driving operational excellence and continuous improvement. The successful candidate will lead and develop a team of QA professionals, foster cross-functional collaboration, and ensure high-quality execution of batch record review, corrective work order management, and inspection readiness activities.

In this role, you will:

• Lead and manage people, processes, technology, and financial resources within Manufacturing Quality Assurance (MQA), ensuring alignment with department and site objectives.
• Provide leadership, coaching, mentoring, and development for a team of Manufacturing Quality professionals through goal setting, performance management, succession planning, and capability building.
• Foster an inclusive, collaborative, and accountable work environment while strengthening team expertise in GMP compliance, quality systems, documentation practices, and risk-based decision making.
• Effectively communicate and influence across all levels of the organization by soliciting input, explaining complex concepts, sharing technical expertise, and building alignment on quality and compliance priorities.
• Lead MQA support for manufacturing operations, ensuring compliance with GMP regulations, site procedures, quality standards, and regulatory expectations.
• Provide technical and quality oversight for: Initial batch record review Compound record review Corrective work order execution and documentation Clinical and commercial batch review, including verification of compliance with specifications through sampling and statistical process control methodologies
• Serve as a quality leader for investigations, change controls, escalation activities, and configuration management processes, ensuring timely communication and resolution of quality events.
• Ensure quality decisions are timely, risk-based, and compliant with applicable regulatory and company requirements.
• Develop, lead, and maintain inspection readiness programs, providing Quality Assurance expertise during internal audits, regulatory inspections, and interactions with health authorities.
• Partner with site leadership to promote a strong culture of quality, compliance, continuous improvement, and operational excellence.
• Collaborate across Manufacturing, Engineering, Supply Chain, Validation, Regulatory, and Quality organizations to drive alignment on quality priorities and business objectives.
• Support departmental budget planning, cost management, resource allocation, and execution of regulatory commitments.
• Monitor quality performance metrics, analyze trends, and utilize data to drive proactive improvements in compliance, quality system effectiveness, and operational efficiency.
• Lead continuous improvement initiatives focused on: Right-first-time documentation Reduction of documentation errors and rework Process simplification and standardization Quality system effectiveness
• Identify and implement innovative improvements to processes, systems, and products while balancing risk, compliance, and business needs.
• Ensure inspection-ready documentation practices and drive consistency in quality system execution, corrective actions, compliance monitoring, and documentation standards.

Here Is What You Need (Minimum Requirements)

• Bachelor's degree with at least 4 years of experience; OR Master's degree/MBA with at least 2 years of experience; OR PhD/JD with 0+ years of experience; OR Associate's degree with at least 8 years of experience; OR High School Diploma (or equivalent) with at least 10 years of relevant experience.
• Substantial experience in pharmaceutical manufacturing, quality assurance, and/or quality control.
• Strong working knowledge of Current Good Manufacturing Practices (cGMP), including experience managing compliance issues, deviations, investigations, and product quality concerns.
• Extensive knowledge of pharmaceutical quality systems, corporate quality standards, vendor management programs, and applicable industry regulations.
• Demonstrated people leadership and management experience.
• Strong critical thinking, problem-solving, and proactive decision-making skills.
• Proven ability to collaborate effectively, build relationships, and work across cross-functional teams.
• Excellent written and verbal communication skills.
• Advanced computer proficiency in Microsoft Office applications (Word, Excel, Access, Project) and enterprise systems such as SAP, LIMS, Veeva Vault, TrackWise, Documentum, and other Quality Management Systems (QMS).

Bonus Points If You Have (Preferred Requirements)

• Strong analytical and problem-solving skills
• Ability to work independently and make decisions
• Excellent organizational and time management skills
• Experience in interfacing with regulatory agencies during audits
• Ability to drive continuous improvement initiatives
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

PHYSICAL/MENTAL REQUIREMENTS

Ability to wear required personal protective equipment (PPE) and comply with gowning requirements for classified manufacturing areas.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Ability to support manufacturing operations outside of standard business hours as needed, including evenings, weekends, holidays, and periodic on-call responsibilities.

OTHER JOB DETAILS

 

Last Date to Apply for Job: 11/9/26

Work Location Assignment: On Premise

The annual base salary for this position ranges from $106,000.00 to $176,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control