Job Description

Use Your Power for Purpose

At Pfizer, everything we do every day is driven by an unwavering commitment to delivering high-quality, safe, and effective products to patients. Our adaptable, innovative, and customer-focused quality culture ensures that your contributions in development, maintenance, compliance, or analysis through research programs will directly benefit patients. Your leadership will help us continue to meet and exceed the requirements of Pfizer and regulatory authorities, ensuring the quality of our products and fostering a culture of continuous improvement and innovation.

What You Will Achieve

Lead Quality Control (QC) Operations for Pfizer’s Andover, MA site by setting strategy, ensuring compliant and efficient laboratory execution, and developing a high-performing organization. Serve as a member of the Site Quality Leadership Team and partner with Site Operations and network functions to deliver on-site and enterprise priorities across commercial and clinical portfolios.

• Lead a ~200-person QC organization (including contractors) delivering analytical, bioanalytical, biological, and microbiological testing for raw materials, intermediates, drug substance, and drug product.

• Define and execute the future-state vision for site QC capabilities, including facility and technology expansion to meet current and pipeline demand.

• Partner with site and network stakeholders to integrate QC needs into the site master plan and long-range capacity strategy.

• Ensure end-to-end compliance and inspection readiness for all QC activities supporting commercial and clinical products, including release, stability, and in-process testing and oversight of external contract testing.

• Oversee method transfer (incoming and outgoing), method validation, and analytical support for regulatory filings, new registrations, and new product introductions.

• Own QC laboratory systems and data integrity, including LIMS interface, investigation oversight, and continuous modernization of laboratory processes and tools.

• Build strong partnerships with Analytical Research & Development (ARD) to enable timely and robust analytical transfers.

• Collaborate with MSAT to align on method development, assay robustness, and technical problem-solving.

• Plan and resource QC capacity and staffing to meet site demand while developing organizational capability through coaching, performance management, and succession planning.

• Own a QC operating budget >$20M, identify value opportunities, and deliver cost savings/cost avoidance through continuous improvement.

• Embed Pfizer’s Production System / Integrated Manufacturing Excellence (IMEx) in QC operations to strengthen standard work, visual management, and performance.

• Set clear objectives, conduct regular 1:1s, coach and develop leaders, and complete performance reviews to build a high-performing, inclusive organization.

• Approve cGMP QC documentation, lead complex cross-functional initiatives, implement continuous improvement, and represent QC Operations in site, network, and enterprise forums.

Successful candidates will demonstrate:

• Demonstrated breadth and depth in cGMP expectations and quality systems, with the ability to influence site compliance strategy across multiple functional areas.

• Proven leadership of QC laboratories across analytical and microbiological disciplines in a regulated (biotech/pharma) environment.

• Ability to generate, interpret, and act on performance metrics; drive sustainable improvements in quality and efficiency (e.g., Lean/Six Sigma, RFT/yellow-belt activities).

• Sound judgment applying and interpreting cGMPs for both commercial and clinical manufacturing environments.

• Recognized subject matter expertise supporting audits/inspections and partnering effectively with ARD and other technical organizations across the Pfizer network.

• Capability to lead complex quality discussions, make timely decisions on technical/compliance issues, and represent QC Operations in cross-site and cross-network forums.

• Experience reviewing trend data and aligning corrective/preventive actions with key stakeholders.

• Commitment to coaching and talent development, including assessing training needs and enabling strong development plans.

• Ability to interpret complex data, draw clear conclusions, and translate findings into executable next steps.

• Structured problem-solving skills and comfort operating in ambiguity while managing risk appropriately.

• Strong cross-functional collaboration skills to gather inputs, align priorities, and deliver outcomes across the Site and Network as applicable.

• Proactive issue identification and timely escalation to senior leadership.

• Growth mindset demonstrated through seeking mentorship, adopting best practices, and continuously improving self and the organization.

• Ability to set priorities for self and teams and deliver critical outcomes with high business impact.

• Commitment to open communication and effective technical exchange within and across teams.

• Strong interpersonal skills (e.g., negotiation, conflict management) to influence outcomes and sustain engagement.

• Strong decision-making that considers enterprise impact on future quality, compliance, and patient supply.

• Experience benchmarking across organizations to identify and replicate best practices and implement scalable processes.

• Consistent demonstration of strong leadership behaviors aligned with Pfizer values.

Working knowledge of U.S., EU, and rest-of-world cGxP expectations; proficiency with Microsoft Office (Word, Excel, PowerPoint, Project); and demonstrated use of Lean Six Sigma, quality systems, and quality risk management (including risk assessments). Experience applying project management and stakeholder management tools is required.

Preferred experience with Laboratory Information Management Systems (LIMS), Global Quality Tracking (TrackWise®), and Systems, Applications, and Products (SAP).

How You Will Achieve This

• Lead QC laboratory teams to consistently apply site and corporate standards (cGMP and EHS) to maintain a safe, compliant, and effective operation.

• Own QC governance and documentation (policies, SOPs, and supporting records) to ensure accuracy, compliance, and inspection readiness.

• Ensure QC laboratory systems and data integrity controls remain compliant, validated, and audit-ready to support reliable decision-making.

• Deliver timely testing and release of raw materials, in-process materials, finished product, and stability samples in accordance with licensed specifications and site priorities.

• Standardize QC practices across functional areas and drive operational excellence using IMEx tools, visual management, and standard work.

• Modernize QC capabilities by evaluating, implementing, and scaling new testing technologies and automation in partnership with site and network teams.

• Provide QC technical leadership for product testing, registrations, and new product introductions, including method transfer/validation and regulatory-support activities.

• Lead laboratory trending and provide high-quality data packages to support Annual Product Record Reviews (APRRs) and proactive performance management.

• Own QC financial performance by building and managing capital and expense budgets, maintaining capacity plans, and tracking KPIs to optimize cost and service.

• Develop and retain talent by setting role expectations, establishing training curricula, providing ongoing coaching/feedback, and completing performance appraisals.

• Role model Pfizer values and the site “All In” culture; coach others to consistently demonstrate expected behaviors.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience

• 8 years of Quality Control experience across Analytical and Microbiology.

• Demonstrated leadership experience; experience leading people leaders and directing a large, complex organization is preferred.

• Extensive people management and talent development expertise

• Deep understanding of GMPs

• Effective communication skills, both written and verbal

• Strong interpersonal skills

• Ability to juggle multiple projects simultaneously

• Robust problem-solving capabilities

Bonus Points If You Have (Preferred Requirements):

• Experience supporting Board of Health inspections and engaging effectively with inspectors is preferred.

Other Job Details:

• Last day to Apply: June 6th, 2026

• Work Location Assignment: On Premise

The annual base salary for this position ranges from $176,600.00 to $294,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% 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.

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