Vice President External Supply Operations Quality
About The Position
Use Your Power for Purpose Patients count on us to get quality right every time, everywhere. As VP, External Supply Operations Quality (ESOQ), you’ll set the global quality vision for external supply, partnering across stakeholders and CMOs to deliver reliable, compliant product supply worldwide. The VP, Vice President, External Supply Operations Quality (VP ESOQ) is responsible for ensuring that all products manufactured by Contract Manufacturing Organizations (CMOs) meet company standards and global regulatory requirements. The VP ESOQ also sets the vision and direction for external quality operations which includes Quality oversight for PC1, Alliances and Partnerships; ensures regulatory readiness, and partners closely with internal and external stakeholders to enable reliable, compliant supply in support of Pfizer’s business objectives and patient commitments. What You Will Achieve Strategic Leadership & Quality Governance Define and lead the global quality strategy for Pfizer’s external manufacturing network, ensuring alignment with enterprise objectives and evolving regulatory expectations. Own the compliance framework for third party operations, with a strong focus on proactive risk identification, mitigation, and continuous improvement. Serve as a senior quality leader and thought partner to stakeholders, influencing decisions across a highly matrixed organization. External Partner & CMO Quality Management Establish and oversee comprehensive contractor quality management programs, including CMO selection, qualification, onboarding, and ongoing performance monitoring. Partner with RQA to determine GxP audit strategy for external partners. Use data to drive successful BOH inspection outcomes (e.g., FDA, EMA, PMDA) at CMOs. Monitor and support the effective completion of CAPA. Ensure robust governance, transparency, and accountability across the external supply base. Quality Agreements & Regulatory Compliance The ESOQ team leads the negotiation, execution, and lifecycle management of Quality Agreements with CMOs clearly defining quality expectations, roles, and responsibilities. Ensure all external manufacturing activities comply with current Good Manufacturing Practices (cGMP), ISO standards, applicable regulations, and ICH guidelines. Quality Risk Management & Issue Resolution Embed Quality Risk Management principles across the external network to proactively manage compliance and operational risks. Oversee investigations related to deviations, complaints, and quality events, ensuring timely, effective root cause analysis and sustainable corrective and preventive actions. People Leadership & Capability Building Build, lead, and develop a high performing global quality organization, fostering a culture of accountability, inclusion, continuous improvement, and compliance excellence. Attract, retain, and develop top talent, ensuring strong succession planning and organizational resilience. Financial & Operational Stewardship Manage significant departmental budgets, ensuring disciplined financial oversight and data driven assessment of investments, risks, and resource allocation. The VP of External Supply Quality oversees the compliance infrastructure for third-party operations, focusing on strategic direction and risk management. Develop and implement global quality strategies for the external network that align with company business objectives. Ensure all external manufacturing activities comply with current Good Manufacturing Practices (cGMP), ISO standards, and other federal regulations. Establish and direct supplier quality management programs, including rigorous supplier selection, qualification, and ongoing performance monitoring. Lead the negotiation, execution, and periodic review of Quality Agreements with CMOs/CDMOs to clearly define quality expectations and responsibilities. Implement Quality Risk Management (QRM) principles (ICH Q9) to proactively identify and mitigate compliance risks. Oversee the investigation of deviations, customer complaints, and root cause analyses to ensure timely resolution.
Requirements
- Bachelor’s degree is required and a minimum of 15+ years of progressive leadership experience in Quality, Manufacturing, External Supply, or related roles within the pharmaceutical or regulated life sciences industry.
- Deep expertise in global regulatory requirements (FDA, EMA, PMDA) and ICH guidelines, with a strong track record of regulatory inspection management.
- Ability to influence stakeholders across a matrix organization and negotiate with external partners without direct positional authority.
- Proven capability to define a forward-looking quality vision and drive alignment and execution.
- Experience managing large, complex budgets and making sound, data driven decisions related to risk, cost, and performance.
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Nice To Haves
- Master’s degree preferred.
Responsibilities
- Define and lead the global quality strategy for Pfizer’s external manufacturing network, ensuring alignment with enterprise objectives and evolving regulatory expectations.
- Own the compliance framework for third party operations, with a strong focus on proactive risk identification, mitigation, and continuous improvement.
- Serve as a senior quality leader and thought partner to stakeholders, influencing decisions across a highly matrixed organization.
- Establish and oversee comprehensive contractor quality management programs, including CMO selection, qualification, onboarding, and ongoing performance monitoring.
- Partner with RQA to determine GxP audit strategy for external partners.
- Use data to drive successful BOH inspection outcomes (e.g., FDA, EMA, PMDA) at CMOs.
- Monitor and support the effective completion of CAPA.
- Ensure robust governance, transparency, and accountability across the external supply base.
- The ESOQ team leads the negotiation, execution, and lifecycle management of Quality Agreements with CMOs clearly defining quality expectations, roles, and responsibilities.
- Ensure all external manufacturing activities comply with current Good Manufacturing Practices (cGMP), ISO standards, applicable regulations, and ICH guidelines.
- Embed Quality Risk Management principles across the external network to proactively manage compliance and operational risks.
- Oversee investigations related to deviations, complaints, and quality events, ensuring timely, effective root cause analysis and sustainable corrective and preventive actions.
- Build, lead, and develop a high performing global quality organization, fostering a culture of accountability, inclusion, continuous improvement, and compliance excellence.
- Attract, retain, and develop top talent, ensuring strong succession planning and organizational resilience.
- Manage significant departmental budgets, ensuring disciplined financial oversight and data driven assessment of investments, risks, and resource allocation.
- Develop and implement global quality strategies for the external network that align with company business objectives.
- Ensure all external manufacturing activities comply with current Good Manufacturing Practices (cGMP), ISO standards, and other federal regulations.
- Establish and direct supplier quality management programs, including rigorous supplier selection, qualification, and ongoing performance monitoring.
- Lead the negotiation, execution, and periodic review of Quality Agreements with CMOs/CDMOs to clearly define quality expectations and responsibilities.
- Implement Quality Risk Management (QRM) principles (ICH Q9) to proactively identify and mitigate compliance risks.
- Oversee the investigation of deviations, customer complaints, and root cause analyses to ensure timely resolution.
Benefits
- participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
- eligibility to participate in our share based long term incentive program
- 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
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Number of Employees
5,001-10,000 employees
