[Pfizer] Manager, GMP GDP Auditor
Pfizer · Aichi, Japan
QualityFull-timeCompany career page
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Role summary
Regulatory Quality Assurance role focused on GMP/GDP auditing of Pfizer manufacturing facilities, contract manufacturers, and suppliers globally. The manager will lead complex audits independently, apply knowledge of international regulations and standards, and support quality compliance programs with minimal oversight.
What they're looking for
- Bachelor's degree in pharmaceutical or natural sciences, or equivalent
- Advanced knowledge of global regulations (FDA, ICH, PIC's, EMA, HC, ANVISA, TGA) and international standards (ISO, WHO)
- Comprehensive working knowledge of GMP/GDP regulations, business concepts, and quality operations
- Strong critical thinking and risk assessment skills for audit planning and execution
- Technical writing skills and ability to identify data trends and patterns
- Specialization in at least one conventional technology (API, solid oral dosages, etc.)
- 5-7 years operational or auditing experience preferred; vendor audit expertise and bilingual Japanese/English ability preferred
What you'll be doing
- Plan and lead complex audits of material suppliers, service providers, and Pfizer facilities independently
- Participate in audits of manufacturing sites and contract manufacturers; conduct initial and routine audits
- Leverage AI tools to support audit preparation, execution, and reporting with appropriate human oversight
- Execute quality programs related to specific vendor entities and functional area assessments
- Collaborate with RQA colleagues on cross-functional audit plans and identify process improvements
Privacy & handoff
This role links to Pfizer's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.