Related skills
auditing quality assurance gmp qms cdmo📋 Description
- Lead development and execution of QA audit programs for GMP activities
- Oversee CDMOs for drug substance/product in Phase 3 and PPQ
- Perform GMP audits and provide quality guidance on data and docs
- Ensure manufacturing/testing adheres to GMP regulations; drive continuous improvement
- Manage batch record review and release to support clinical supply
- Maintain robust quality systems: documentation, change control, deviations, CAPA
🎯 Requirements
- Bachelor’s degree in a relevant scientific discipline; advanced degree a plus
- 10+ years GMP QA in biotech/pharma, with auditing and biologics
- CDMO oversight experience, partnering and aligning on quality issues
- In-depth knowledge of GMP regs (FDA, EMA, ICH)
- Analytical methods, validation, investigations; stability program; electronic QMS
- Strong communication and problem-solving; able to travel up to 20%
🎁 Benefits
- C.O.R.E. values: Caring, Original, Resilient, Egoless
- Fast-paced environment with opportunities to wear multiple hats
- Competitive compensation and benefits package
- Generous time off: PTO, company shutdowns, paid sick leave
- Professional development opportunities and resources
- All-team in-person meetings to build relationships
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