External Supply GB1 – IM & Spec Operations Quality Lead

Use Your Power for Purpose

The External Supply GB1 – IM & Spec Operations Quality Lead is accountable for quality assurance oversight of contract manufacturers (CMOs) worldwide that supply Pfizer’s Global BioPharma 1 (GB1) – IM & Spec portfolio. The role provides strategic and operational quality leadership across External Supply, enabling timely, risk-based quality and compliance decisions that protect product quality and patient safety.

This highly independent role requires the maturity to operate effectively in a risk-based, virtual environment while maintaining compliance with current Good Manufacturing Practices (cGMPs) across a broad portfolio of CMO.

The position reports to the VP, External Supply Operations Quality (ESOQ), serves as a core member of the ESOQ Leadership Team, and is based in the United States. The role partners closely with the GB1 – EMC ESOQ Lead to ensure aligned quality oversight across the Global BioPharma 1 external network.

What You Will Achieve

• Provide quality leadership to cross-functional Virtual Site Operating and Site Leadership Teams (VSOT/VSLT).
• Champion IMEx standard work and continuous improvement, advancing Revolution and the broader ESOQ transformation agenda through digital and AI-enabled ways of working.
• Drive data-driven quality oversight, using quality performance metrics and leading indicators to inform risk-based CMO performance management and decision-making.
• Lead Pfizer support for Board of Health inspections at CMOs, including review of regulatory responses and oversight of effective CAPA implementation.
• Drive proactive inspection readiness across the CMO network, including oversight of sites under heightened regulatory scrutiny or remediation, and ensure quality oversight keeps pace with evolving regulatory expectations.
• Influence CMO quality systems and product quality performance through strong collaboration with Pfizer partner functions and CMO leadership.
• Assess portfolio risk, identify emerging trends, and ensure timely escalation and mitigation.
• Build an empowering environment that enables colleague performance, growth, and development. This includes building talent pipelines and deepening quality capability across the team.
• Provide quality leadership for significant CMO deviations, investigations, and remediation initiatives, escalating issues within Pfizer and with CMO leadership as needed.
• Ensure on-time disposition of commercial products in line with agreed schedules.
• Partner with External Supply New Product and Global Launch teams to enable successful commercial launches, including quality oversight of product onboarding and technology transfers into the Pfizer network.
• Provide quality input into CMO selection, due diligence, and external network strategy decisions for the GB1 – IM & Spec portfolio, supporting portfolio growth.
• Maintain effective partnerships across Center QO/EHS, External Supply, Regulatory, GSC, GTEL, and other relevant functions.
• Serve as a member of the GB1 External Supply Leadership Team.
• Contribute to the development and execution of the ESOQ strategic agenda as a core member of the ESOQ Leadership Team.

Here Is What You Need (Minimum Requirements)

• Bachelor’s degree with at least 12+ years of experience; OR a Master’s degree with more than 10+ years of experience; OR a Ph.D. with 7+ years of experience.
• Experience within pharmaceutical industry experience, including leadership roles requiring strong knowledge of GMP regulations.
• Direct experience within a quality unit and excellent critical thinking capabilities.
• Demonstrated people leadership, including developing and coaching colleagues through organizational and business transformation.
• Strong knowledge of pharmaceutical quality and manufacturing operations.
• Proven ability to lead organizational change and business transformation.
• Strong strategic, analytical, and critical-thinking skills, with the ability to solve complex problems, draw sound conclusions, and recommend improvements.
• Well-developed interpersonal and influencing skills, with the ability to collaborate effectively with internal and external stakeholders at all organizational levels.

Bonus Points If You Have (Preferred Requirements)

• Knowledge of Integrated Manufacturing Excellence (IMEx) or comparable lean manufacturing approaches.
• Experience leveraging digital tools, data analytics, or AI-enabled ways of working to strengthen quality oversight and decision-making.
• Demonstrated experience guiding CMOs or manufacturing sites through significant regulatory findings or remediation is preferred.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Approximately 15–20% travel.
• Flexible working hours to support global operations.

 
Other Job Details:
Work Location Assignment: Hybrid

Relocation Assistance: No

Last date to apply: 9/23/26

The annual base salary for this position ranges from $230,900.00 to $384,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% 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. This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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