Manager, GMP Audits
Pfizer · Wuxi, China +1 more
QualityRemoteFull-timeCompany career page
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Role summary
Pfizer seeks a Manager for GMP/GDP audits to lead quality compliance assessments of manufacturing facilities, suppliers, and service providers globally. The role involves planning and executing audits, applying regulatory expertise, and leveraging audit technologies to ensure adherence to pharmaceutical manufacturing standards.
What they're looking for
- Bachelor's degree in pharmaceutical or natural sciences or equivalent
- Advanced knowledge of global regulations (FDA, ICH, EMA, ANVISA, TGA) and international standards
- 5-7 years of operational or auditing experience preferred
- Expertise in vendor audits and at least one technology area (APIs, sterile biologics, small molecules, GDP)
- Critical thinking skills to identify and assess compliance risks strategically
- Technical writing and data analysis capabilities
- Willingness to adopt AI tools and digital audit methodologies
What you'll be doing
- Plan and lead complex audits of suppliers, service providers, and Pfizer facilities independently
- Execute initial and routine GMP/GDP audits with minimal oversight
- Support quality programs related to functional areas and vendor assessments
- Resolve compliance issues using regulatory knowledge and standard operating procedures
- Collaborate with RQA colleagues on cross-functional audit plans and stakeholder management
Privacy & handoff
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