Quality Lead, Manager

Pfizer

Quality Lead managing compliance and product quality for Pfizer’s external manufacturing network. Ensuring adherence to quality standards for contract manufacturers and suppliers with a focus on continuous improvement.

Posted 7/28/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing product quality and compliance within the pharmaceutical industry, with a strong focus on external suppliers and contract manufacturers. Proficient in quality assurance practices, regulatory compliance, and leading cross-functional teams to drive continuous improvement initiatives.

Highest-signal resume keywords

Quality Assurance ManagementRegulatory Compliance (GMP/GDP)Pharmaceutical Manufacturing ExperienceVendor Risk ManagementTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Improvement PlansQuality Review Teams (QRTs)Quality Action Notices (QANs)Batch Disposition EndorsementContinuous Improvement InitiativesCGxP KnowledgeProduct Quality Reviews (PQR)Annual Product Reviews (APR)Risk AssessmentsAuditing Activities

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationPresentation SkillsProblem SolvingLeadership

Tools & Technologies

MS OfficeSAPQTSEQMS

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryExternal SuppliersContract ManufacturersQuality Agreements

About the role

Key responsibilities & impact

Manage all aspects related to product quality and compliance for a portfolio of external contract manufacturers and suppliers delivering materials and/or products to Pfizer, in accordance with established procedures
Assess the quality of external suppliers’ products, manufacturing processes, and related documentation, ensuring product specifications are met and quality systems are maintained
Support internal and external partners with auditing activities related to ESOQ operations and contractor portfolios, including RQA audits and regulatory inspections, as applicable
Support internal and external partners with Compliance Assessments to ensure ongoing GMP/GDP adherence
Manage vendor risk by implementing Quality Improvement Plans and supporting risk assessments, Quality Review Teams (QRTs), and Quality Action Notices (QANs), as required
Support onboarding activities for new CMOs and product launches within the assigned portfolio
Support offboarding activities for exiting CMOs, products, or SKUs within the portfolio
Make product quality decisions by leveraging comprehensive knowledge of Quality and Manufacturing principles, prior work experience, and technical expertise, while ensuring compliance with global regulatory and Pfizer requirements
Influence quality decision‑making in alignment with industry standards and Pfizer requirements
Provide Quality leadership within cross‑functional Virtual Site Operating Teams (VSOTs)
Partner with colleagues to develop, review, and negotiate Quality Agreements
Review and approve Annual Product Reviews (APR), Product Quality Reviews (PQR), and relevant product stability reports
Perform batch disposition endorsement in accordance with Pfizer requirements
Identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with evolving internal and external standards
Ensure accurate tracking, documentation, and escalation of all required quality‑related actions in the relevant systems
Lead and support complex investigations, market complaints, and risk assessments for products within the portfolio; raise NTMs and engage SMEs as needed
Provide performance metrics and reporting for key quality performance indicators
Work independently, receiving guidance primarily on unusual or complex issues
Build, maintain, and further develop strong relationships with key internal and external stakeholders

Requirements

What you’ll need

Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline
Minimally 5 years’ experience in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 10 years’ experience in the pharmaceutical or medical device industry
Experience with external suppliers/contractors
Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, eQMS
Proficient in English and technical writing
Strong verbal, written communication, and presentation skills
Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives
Demonstrated experience managing complex quality and compliance activities
Problem solving attitude and open to innovation
Demonstrated managerial/organizational skills
Strong critical thinking and proactive, persistent approach
Good organizing and planning skills and a high sense of urgency
Demonstrated ability to act and work independently, to take initiative and to report items as required to line manager
Demonstrated knowledge of US, European and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices
Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives
Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role

Benefits

Comp & perks

Flexible working hours
Professional development opportunities