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, clinical and commercial manufacturing sites, and contract manufacturers .

Posted 10/12/2026full-timeRemote • Egypt, South Africa, Morocco, Saudi Arabia, United Arab EmiratesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Good Distribution Practices and global regulatory requirements, including FDA and ICH, while effectively managing audits and quality programs. Proficient in data analytics and technical writing, with strong organizational and project management skills to assess compliance risks and develop strategic audit approaches.

Highest-signal resume keywords

Good Distribution Practices ExpertiseGlobal Regulatory KnowledgeData Analytics ProficiencyTechnical Writing SkillsAudit Management Experience

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Good Distribution PracticesGlobal RegulationsData AnalyticsTechnical WritingQuality OperationsAudit FrameworksRisk AssessmentProject ManagementSOPs ComplianceVendor Audits

Soft Skills

Organizational SkillsCollaborationProblem-SolvingCritical ThinkingCommunication

Tools & Technologies

AI ToolsAudit TechnologiesQuality Management SystemsData Interpretation ToolsElectronic Observation Tools

Industry Keywords

PharmaceuticalMAH Regulatory RequirementsWDA Regulatory RequirementsISO StandardsWHO StandardsGMP RegulationsGDP RegulationsClinical ManufacturingCommercial ManufacturingMatrix Model Functionality

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, clinical and commercial manufacturing sites, and contract manufacturers
Manage and lead audits with minimal oversight
Use AI tools responsibly to support targeted audit preparation and execution
Engage with complex process audits and review low-complexity outsourced audits
Support and execute quality programs related to functional areas, vendor entities, and assessments
Resolve issues using relevant SOPs, GMP/GDP regulations and standards, and local regulations
Work 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 functional lines and vendors
Assess quality and compliance risks through field-based observation, including physical and electronic activities

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
Comprehensive working knowledge of business concepts and quality operations
Ability 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 GDPs
Ability to function autonomously in a matrix model and in a team environment
Ability to travel up to 40% of the time, including domestic and international travel

Benefits

Comp & perks

Ability to work remotely
Equal employment opportunity employer
Responsible use of AI tools supported during audit preparation and execution
Opportunity to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies