MQA Manufacturing Technical Lead

Pfizer • Sanford, NC

5d • Onsite

About The Position

The MQA Manufacturing Technical Lead provides strategic leadership and oversight of Quality Assurance support for manufacturing operations. The role ensures compliance with GMP requirements, regulatory expectations, and internal quality standards while driving operational excellence and continuous improvement. It leads and develops a team of QA professionals and supports high-quality execution of batch record reviews, corrective work order management, and inspection readiness activities.

The position leads people, processes, technology, and financial resources within Manufacturing Quality Assurance, aligning work with department and site objectives. It provides technical and quality oversight for initial and compound batch record review, corrective work order execution and documentation, and clinical and commercial batch review, including specification compliance checks using sampling and statistical process control methods. The role also leads investigations, change controls, escalation activities, and configuration management processes, and makes timely, risk-based quality decisions.

The lead develops and maintains inspection readiness programs and provides QA expertise during internal audits, regulatory inspections, and health authority interactions. In partnership with site leadership and cross-functional organizations, the role promotes quality, compliance, continuous improvement, and operational excellence. It supports budget planning, cost management, resource allocation, and regulatory commitments; monitors quality metrics and trends; and leads initiatives to improve right-first-time documentation, reduce errors and rework, simplify and standardize processes, and strengthen quality systems.

The position is on-premise and may require support for manufacturing operations outside standard business hours, including evenings, weekends, holidays, and periodic on-call responsibilities. The role requires wearing personal protective equipment and complying with gowning requirements in classified manufacturing areas.

Requirements

• One of the following education and experience combinations: bachelor's degree and at least 4 years of experience; master's degree or MBA and at least 2 years; PhD or JD and 0+ years; associate degree and at least 8 years; or high school diploma or equivalent and 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.
• Ability to collaborate effectively, build relationships, and work across cross-functional teams.
• Excellent written and verbal communication skills.
• Advanced computer proficiency with Microsoft Office applications, including Word, Excel, Access, and Project, and enterprise systems such as SAP, LIMS, Veeva Vault, TrackWise, Documentum, and other Quality Management Systems.
• Ability to wear required personal protective equipment and comply with gowning requirements for classified manufacturing areas.
• Ability to support manufacturing operations outside standard business hours as needed, including evenings, weekends, holidays, and periodic on-call responsibilities.
• Permanent work authorization in the United States; work visa sponsorship is not available.

Nice To Haves

• Strong analytical and problem-solving skills.
• Ability to work independently and make decisions.
• Excellent organizational and time management skills.
• Experience 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 productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Lead and manage people, processes, technology, and financial resources within Manufacturing Quality Assurance, aligning them with department and site objectives.
• Coach, mentor, and develop Manufacturing Quality professionals through goal setting, performance management, succession planning, and capability building.
• Foster an inclusive, collaborative, and accountable work environment and strengthen team expertise in GMP compliance, quality systems, documentation practices, and risk-based decision making.
• Communicate and influence across organizational levels, explain complex concepts, share technical expertise, and build alignment on quality and compliance priorities.
• Lead MQA support for manufacturing operations and ensure 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, and clinical and commercial batch review.
• Verify batch compliance with specifications using sampling and statistical process control methodologies.
• Lead 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 regulatory and company requirements.
• Develop and maintain inspection readiness programs and provide QA expertise during internal audits, regulatory inspections, and interactions with health authorities.
• Partner with site leadership to promote quality, compliance, continuous improvement, and operational excellence.
• Collaborate with Manufacturing, Engineering, Supply Chain, Validation, Regulatory, and Quality teams to align 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 use data to drive improvements in compliance, quality system effectiveness, and operational efficiency.
• Lead continuous improvement initiatives focused on right-first-time documentation, reducing documentation errors and rework, process simplification and standardization, and quality system effectiveness.
• Identify and implement process, system, and product improvements while balancing risk, compliance, and business needs.
• Ensure inspection-ready documentation practices and consistent execution of quality systems, corrective actions, compliance monitoring, and documentation standards.

Benefits

• 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.
• Medical, prescription drug, dental, and vision coverage.
• Participation in Pfizer’s Global Performance Plan with a 15% bonus target.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior