Vice President, Global GMP Quality
Mirum Pharmaceuticals, Inc.
August 24, 2026
On-site
Foster City, CA
Operations
Position Summary
- Lead GMP quality functional teams at Mirum and subsidiaries (US and International), driving ongoing GMP quality improvement, optimization, innovation, and excellence.
- Manage, mentor, and support clinical and commercial Quality Assurance (QA) and Quality Control (QC) teams; provide hands-on leadership for GMP QA/QC execution, including product quality complaint and root-cause investigations, and reporting critical GMP issues to executive management.
- Ensure GMP/GDP quality processes meet FDA, EMA, and other international regulatory requirements, corporate objectives, and industry best practices; align GMP/GDP quality initiatives with broader strategic goals.
Job Functions/Responsibilities
- Develop and execute global GMP quality strategy; lead GMP QA/QC teams’ professional development.
- Oversee GMP/GDP process development/optimization; lead audits and regulatory inspections, CAPA strategy, and inspection readiness.
- Host/Manage GMP PAI/PLI inspections; support CMO inspections.
- Oversee GMP QA/QC for drug manufacturing, clinical/commercial product release, Material Review Board (MRB) designee role, and global recall strategy/recall committee.
- Collaborate with Commercial on launch/NPP-EAP-CUP programs; approve GMP/GDP and partner/distributor quality agreements; oversee APQR review.
- Assess CMO/CTL audit outcomes; provide quality SME input; lead quality excellence and continuous improvement.
Qualifications
- BS in biochemistry/chemistry/biology or related (advanced degree preferred).
- 15+ years pharma/biotech QA experience; 10+ years in quality leadership and/or people management.
- Strong cGMP knowledge (FDA/EMA); comprehensive GMP/GDP/ISO/ICH and global regulatory knowledge.
- Experience with inspection readiness; cross-functional collaboration across global regions.
- Preferred: Product quality complaints and pharmacovigilance quality experience; rare disease/biologics experience.
Skills/Abilities
- Hands-on product lifecycle management; cross-functional leadership and people management across cultures.
- Strong analytical/problem-solving and technically driven decision-making; ethics; clear communication.
Travel: Requires at least 15% domestic/international travel.
- Lead GMP quality functional teams at Mirum and subsidiaries (US and International), driving ongoing GMP quality improvement, optimization, innovation, and excellence.
- Manage, mentor, and support clinical and commercial Quality Assurance (QA) and Quality Control (QC) teams; provide hands-on leadership for GMP QA/QC execution, including product quality complaint and root-cause investigations, and reporting critical GMP issues to executive management.
- Ensure GMP/GDP quality processes meet FDA, EMA, and other international regulatory requirements, corporate objectives, and industry best practices; align GMP/GDP quality initiatives with broader strategic goals.
Job Functions/Responsibilities
- Develop and execute global GMP quality strategy; lead GMP QA/QC teams’ professional development.
- Oversee GMP/GDP process development/optimization; lead audits and regulatory inspections, CAPA strategy, and inspection readiness.
- Host/Manage GMP PAI/PLI inspections; support CMO inspections.
- Oversee GMP QA/QC for drug manufacturing, clinical/commercial product release, Material Review Board (MRB) designee role, and global recall strategy/recall committee.
- Collaborate with Commercial on launch/NPP-EAP-CUP programs; approve GMP/GDP and partner/distributor quality agreements; oversee APQR review.
- Assess CMO/CTL audit outcomes; provide quality SME input; lead quality excellence and continuous improvement.
Qualifications
- BS in biochemistry/chemistry/biology or related (advanced degree preferred).
- 15+ years pharma/biotech QA experience; 10+ years in quality leadership and/or people management.
- Strong cGMP knowledge (FDA/EMA); comprehensive GMP/GDP/ISO/ICH and global regulatory knowledge.
- Experience with inspection readiness; cross-functional collaboration across global regions.
- Preferred: Product quality complaints and pharmacovigilance quality experience; rare disease/biologics experience.
Skills/Abilities
- Hands-on product lifecycle management; cross-functional leadership and people management across cultures.
- Strong analytical/problem-solving and technically driven decision-making; ethics; clear communication.
Travel: Requires at least 15% domestic/international travel.