[Pfizer] Manager, GMP GDP Auditor
Core
Conduct independent GMP/GDP audits of Pfizer facilities, contract manufacturers, suppliers, and service providers globally to ensure compliance with global regulations and Pfizer Quality Standards.
Role type
Manager, GMP/GDP Auditor
Builds
Audit plans and reports for manufacturing, packaging, testing, and distribution of APIs, clinical trial materials, and commercial biopharmaceutical products.
Domain
Biopharmaceuticals / Regulatory Quality Assurance
Deliverable
client delivery
Required skills
GMP/GDP regulations knowledge, audit planning and execution, stakeholder management, critical thinking, technical writing, data trend analysis, project management, SOP interpretation, conventional technology specialization (API, solid oral dosages)
Preferred skills
Data analytics, vendor audit expertise, sterile biologics/small molecules/GDP knowledge, autonomous matrix functioning
Technologies
AI tools for audit preparation and execution
Responsibilities
Plan and lead complex audits of material suppliers and service providers; execute routine audits of manufacturing sites; resolve compliance issues based on regulations and SOPs; synthesize stakeholder feedback; suggest and operationalize new audit techniques.
Seniority
Manager, hands-on leadership with minimum oversight