Director, External Supply Operations Quality

Pfizer

. Provide Quality Leadership to cross-functional virtual site operating and leadership teams .

Posted 11/7/2026full-timeUnited StatesLead💰 $176,600 - $294,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Quality Control systems for pharmaceuticals and medical devices, with a strong focus on regulatory compliance, continuous improvement, and team leadership. Proficient in managing complex projects and cross-functional teams while ensuring adherence to GMP and GDP standards.

Highest-signal resume keywords

Quality Assurance LeadershipGMP/GDP Regulatory ComplianceProject ManagementTeam ManagementTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk ManagementCAPA ManagementDMAICSix SigmaPharmaceutical Quality ComplianceBatch CertificationRegulatory Directives KnowledgeQuality System RegulationsManufacturing KnowledgeProblem Solving

Soft Skills

Communication SkillsInfluencing SkillsConflict ResolutionOrganizing SkillsPlanning Skills

Tools & Technologies

MS OfficeSAPQTS/QMSVaultPDMDocumentumMinitabAI Tools

Certifications & Qualifications

Bachelor's DegreeMaster's DegreePhDClinical License

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryGMPGDPQuality AgreementsVirtual TeamsExternal SuppliersRegulatory AgenciesIMExDrug Substance Manufacturing

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Provide Quality Leadership to cross-functional virtual site operating and leadership teams
Lead and develop manager and senior manager colleagues in accordance with Pfizer PEX policies and procedures
Develop, implement and support Quality Assurance and Quality Control systems for APIs, global pharmaceutical products, suppliers and medical devices operated by contract partners
Develop and negotiate Quality Agreements
Ensure GDP oversight during manufacture and shipping of medicinal products
Drive continuous improvement of products, processes and quality systems
Support GMP/GDP regulatory inspections at vendors and review/approve responses to regulatory agencies
Lead significant deviation and customer complaint activities, including CAPA and quality system improvements
Generate QRT summaries and participate in relevant meetings
Lead quality risk management activities and mitigation plans for CMOs and suppliers
Ensure on-time disposition of commercial products
Serve as senior technical/functional expert and provide business direction
Manage complex projects and ongoing work activities
Manage people, technological and financial resources, including 5–6 direct reports
Develop solutions to complex and ambiguous problems and make decisions within the business line/sub-function
Present business issues across departments or business lines
Support ESOQ leadership on other tasks as required
Oversee external testing activities at CTOs for release and stability testing, if applicable

Requirements

What you’ll need

Must have a bachelor's degree, Pharmacy, Engineering or other related science degree preferred, with at least 8 years of experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and/or experience in the pharmaceutical or medical device industry; OR a master's degree with at least 7 years of experience; OR a PhD with 5+ years of experience
Proven success in leading teams and cross functional projects/initiatives
Demonstrated communication and influencing skills across all functions and organizational levels
Demonstrated experience managing a team, directly or indirectly
Ability to manage complex pharmaceutical quality and compliance activities at a manufacturing plant or with a contractor
Investigation skills and knowledge of DMAIC, 6sigma, YB or GB
Ability to manage multiple projects and prioritize work
Demonstrated ability to resolve conflicts
Advanced computer skills with MS Office, SAP, QTS/QMS, Vault, PDM, Documentum, Minitab and AI tools such as CoPilot
Proficient in English, written and spoken
Strong technical writing, verbal, written communication and presentation skills
Demonstrated DEI attitude
Demonstrated clinical and specials license know how
Experience managing batch certification and importation
Strong organizing and planning skills and a high sense of urgency
Detailed knowledge of manufacture and packaging of drug substance, solid oral dose and/or aseptic/sterile pharmaceutical products
In-depth knowledge of quality system regulations and global GMPs
Knowledge of regulatory directives and guidelines, including dossier structure and variation guidelines
Knowledge of IMEx preferred
Postgraduate science-based qualifications preferred
Experience working in virtual teams preferred
Experience managing external suppliers/contractors preferred
Up to 20% travel
Must be authorized to be employed in the U.S. by any employer and have permanent work authorization in the United States
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

Global Performance Plan with a bonus target of 20.0% of base salary
Share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility