Director, External Supply Operations Quality

Pfizer • Tampa, MA

1d • Hybrid

About The Position

The Director, External Supply Operations Quality (ESOQ) provides global Quality Assurance Operational Management oversight of Pfizer contractors that manufacture and/or package pharmaceutical products or devices on behalf of Pfizer Global Supply. ESOQ oversees approximately 400 contract manufacturers, contract testing sites, packagers, suppliers, and supply partners. The role assures the quality of products and services on Pfizer’s behalf and has ultimate responsibility for Pfizer lot disposition decisions. Some positions may also have region-specific responsibilities.

The Director provides Quality leadership to cross-functional virtual site operating and leadership teams, leads the development and support of Quality Assurance and Quality Control systems, and partners with colleagues on Quality Agreements and distribution oversight. The role drives continuous improvement, supports vendor GMP/GDP inspections and regulatory responses, leads significant deviation and complaint investigations, and manages quality risks, remediation, and CAPA. The Director is accountable for timely disposition of commercial products and may oversee external testing for release and stability testing.

This position operates with minimal supervision and interacts with all levels of management at Pfizer and its contract partners. It serves as a senior technical and functional expert, manages complex projects and resources, guides colleagues, and develops solutions to complex and ambiguous problems. The role manages 5–6 direct reports and is accountable for reviewing and approving colleague expenses and ensuring costs remain within budget expectations. Travel of up to 20% is expected. The work location assignment is hybrid.

Requirements

• Bachelor’s degree in Pharmacy, Engineering, or another related science field, with at least 8 years of experience in pharmaceutical or medical-device Quality Assurance roles with direct product-quality decision responsibility and/or experience in the pharmaceutical or medical-device industry; alternatively, a master’s degree with at least 7 years of experience, or a PhD with 5 or more years of experience.
• Proven success leading teams and cross-functional projects or initiatives.
• Demonstrated communication and influencing skills, including the ability to work effectively across functions and organizational levels and build culturally sensitive working relationships.
• Demonstrated experience managing a team, directly or indirectly.
• Demonstrated ability to manage complex quality and compliance activities for pharmaceutical products at a manufacturing plant or with a contractor.
• Investigation skills and knowledge of DMAIC, 6 Sigma, Yellow Belt, or Green Belt methods.
• Ability to manage multiple projects, prioritize work for self and others, and complete work effectively through teamwork.
• Demonstrated ability to resolve conflicts.
• Advanced computer skills with MS Office and enterprise systems such as SAP, QTS/QMS, Vault, PDM, Documentum, Minitab, and AI tools such as CoPilot Pro.
• Proficiency in written and spoken English.
• Strong technical writing, verbal and written communication, and presentation skills.
• Demonstrated DEI attitude.
• Demonstrated clinical and special-license know-how.
• Experience managing batch certification and importation.
• Initiative, proactivity, persistence, strong organization and planning skills, and a high sense of urgency.
• Detailed knowledge of the manufacture and packaging (primary and secondary) of drug substances, solid oral-dose pharmaceuticals, and/or aseptic or sterile pharmaceutical products.
• In-depth knowledge of quality-system regulations and demonstrated ability to evaluate and apply global GMPs to develop effective Manufacturing/QA/QC systems.
• Knowledge of major regulatory directives and guidelines, including dossier structure and variation guidelines.
• Leadership capability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues’ work to achieve meaningful outcomes and business impact.
• Authorization to be employed in the United States by any employer; permanent U.S. work authorization is required. U.S. work visa sponsorship is not available.

Nice To Haves

• Knowledge of IMEx.
• Postgraduate science-based qualifications.
• Experience and personal leadership in virtual teams.
• Experience managing external suppliers or contractors.

Responsibilities

• Provide Quality leadership to cross-functional virtual site operating teams (VSOT) and virtual site leadership teams (VSLT), as appropriate.
• Lead and support the development, implementation, and maintenance of Quality Assurance and Quality Control systems for APIs, global pharmaceutical products, suppliers, and medical devices operated by contract partners, as applicable.
• Partner with colleagues to develop and negotiate Quality Agreements.
• Partner with Global Logistics and Network Services to maintain GDP oversight during the manufacture and shipping of medicinal products, as applicable.
• Drive development, implementation, and continuous improvement of Pfizer products, processes, and quality systems.
• Support GMP/GDP regulatory inspections at vendors and ensure appropriate Pfizer review and approval of responses to regulatory agencies, including tracking corrective and preventive actions.
• Provide Quality leadership for significant deviations or customer complaints at contractor or partner sites that may affect compliance status or require regulatory notifications.
• Ensure effective CAPA implementation and quality-system improvements based on remediation activities.
• Lead generation of QRT summaries, as applicable, and participate in relevant meetings.
• Lead quality risk-management activities and manage mitigation plans within CMOs and suppliers.
• Ensure on-time disposition of commercial products in line with agreed schedules and make Pfizer lot disposition decisions.
• Lead, develop, and support manager- and senior-manager-level colleagues in accordance with Pfizer PEX policies and procedures.
• Manage multiple complex projects and ongoing work, and manage people, technological, and financial resources, including resources outside direct authority.
• Communicate business priorities and issues effectively across departments and business lines, and collaborate with peers and colleagues to achieve business outcomes.
• Support ESOQ leadership on other tasks as required.
• If applicable, oversee external testing activities at contract testing organizations for release and stability testing.
• Manage 5–6 direct reports and review and approve colleague expenses while ensuring costs are managed within budget expectations.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility to participate in Pfizer’s Global Performance Plan, with a 20% target bonus.
• 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: Director