Manager, GMP Audits

Pfizer

. Independently plan, lead, and participate in initial and routine audits of Pfizer manufacturing and distribution operations, license entities, country offices, suppliers, service providers, and commercial/clinical and contract manufacturing sites .

Posted 10/10/2026full-timeRemote • South Africa, China, Egypt, Morocco, Saudi Arabia, United Arab EmiratesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Good Distribution Practices and global regulatory requirements, with a strong focus on quality operations and auditing frameworks. Proficient in data analytics and technical writing, capable of synthesizing information to develop strategic audit approaches.

Highest-signal resume keywords

Good Distribution Practices ExpertiseGlobal Regulatory KnowledgeData Analytics and InterpretationTechnical Writing SkillsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Audit Planning and ExecutionQuality Program SupportSOPs and GMP/GDP RegulationsRisk Assessment and ManagementVendor AuditsConventional Technology SpecializationAI Tools UtilizationContinuous Improvement MethodologiesQuality and Auditing FrameworksComplex Process Audits

Soft Skills

Critical ThinkingCollaborationOrganizational SkillsAutonomous FunctioningStakeholder Management

Tools & Technologies

AI ToolsDigital Audit WorkflowsData Analytics ToolsAudit Technologies

Industry Keywords

FDAICHPIC/SEMAHealth CanadaANVISATGAISOWHOMAH and WDA Regulatory Requirements

About the role

Key responsibilities & impact

Independently plan, lead, and participate in initial and routine audits of Pfizer manufacturing and distribution operations, license entities, country offices, suppliers, service providers, and commercial/clinical and contract manufacturing sites
Use AI tools responsibly to support targeted audit preparation and execution
Engage in complex process audits or review low-complexity outsourced audits
Support and execute quality programs related to functional areas, vendor entities, and assessments
Resolve issues using SOPs, GMP/GDP regulations and standards, and local regulations
Collaborate with RQA colleagues on cross-GxP audit plans
Manage multiple stakeholders, synthesize feedback, and take action with manager support
Collaborate with RQA colleagues and auditees across Pfizer and vendor functional lines
Travel domestically and internationally up to 40% of the time

Requirements

What you’ll need

BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent
Extensive expertise in good distribution practices with complex global distribution models, partners and license entities
Knowledge of MAH and WDA regulatory requirements
Advanced knowledge and understanding of global regulations, including FDA, ICH, PIC/S, EMA, Health Canada, ANVISA, and TGA
Knowledge of international standards, including ISO and WHO
Human oversight, professional judgment, and source verification when using AI tools
Willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies
Comprehensive working knowledge of business concepts and quality operations
Critical thinking to identify and assess areas of greatest risk and develop strategic audit approaches
Understanding of quality and auditing frameworks and their application
Proficient organizational and project management skills
Technical writing skills
Ability to identify trends within data and apply insights to make recommendations
Ability to synthesize information and draw conclusions
Specialization in at least one conventional technology, such as API or solid oral dosages
5–7 years of experience, operational or auditing preferred
Working knowledge of data analytics and interpretation
Expertise in vendor audits plus one technology area, such as MDCP, sterile biologics, small molecules, or GDP
Ability to function autonomously in a matrix model and in a team environment

Benefits

Comp & perks

Equal opportunity employer
Remote work assignment