Director, GMP Quality Assurance Operations
About The Position
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material. This role will be a key cross-functional partner, and will work closely with CMC, Supply Chain, Quality Control, and Regulatory teams to drive quality strategy, continuous improvement, and operational excellence.
Requirements
- Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
- 8+ years of progressive cGMP Quality Assurance experience supporting biologics manufacturing and analytical testing in a regulated environment, Person in Plant, and direct Inspection experience with domestic and international regulatory agencies
- Direct experience managing external partners/CDMOs and ensuring compliance from clinical supply through validation to commercial supply
- Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
Responsibilities
- Manage and provide oversight of routine operations conducted by external partners, including CDMOs and testing labs
- Provide timely feedback for GMP quality events and escalate to management for aligned decisions, as appropriate.
- Ensure timely batch record review, product disposition, and compliance with regulatory requirements
- Develop and monitor partner performance metrics, risk assessments, and escalation pathways
- Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
- Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
- Serve as a primary QA representative during regulatory inspections (FDA, EMA, and other global authorities), including hosting inspections, responding to questions, and managing commitments.
- Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification.
- Champion a culture of quality and inspection readiness across internal and external operations
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What This Job Offers
Job Type
Full-time
Career Level
Director
