Senior Director, Development Quality (GMP)
Mirum Pharmaceuticals, Inc.
6 hours ago
Remote friendly (Foster City, CA)
United States
Operations
Position Summary
- Senior Director, Development Quality (GMP) providing strategic and operational QA oversight for product development from early development through commercialization, ensuring compliance with global GMP and supporting DS/DP/FP development, scale-up, and technology transfer.
Responsibilities
- Lead a compliant, phase-appropriate GMP quality culture across development/technical operations.
- Provide QA oversight across product lifecycle activities (DS/DP/FP) from early stage through commercialization.
- Oversee GMP quality systems: deviations, CAPAs, change control, investigations, product complaints.
- Support clinical manufacturing: batch record review/disposition and release of DS/DP/FP for clinical use.
- Ensure quality oversight of process development, tech transfer, scale-up, and validation.
- Prepare/review/approve CMC sections for IND/NDA/MAA and responses to regulatory questions.
- Support regulatory agencies and GMP inspections (PAIs and general inspections).
- Identify compliance risks and escalate appropriately.
- Oversee GMP vendor management and Quality/Technical Agreements with CMOs/partners.
- Support new product intro/integration, stability programs, QMR/APR/APQR quality metrics, and inspection readiness.
- Build/mentor/lead the Development Quality team and champion quality culture.
Qualifications
- BS in scientific discipline; MS/PhD preferred.
- 15+ years pharma/biotech; 12+ years GMP Quality Assurance.
- Deep knowledge of global GMP (FDA, EMA/EudraLex), ICH, and CGMP regulations.
- Experience with CMC, process validation, tech transfer, clinical manufacturing, IND/NDA/MAA, PAIs, vendor oversight, leadership, supply chain lifecycle management, inspection readiness, and continuous improvement.
Compensation
- Salary range: $275,657 to $310,847 USD (base salary only).
- Senior Director, Development Quality (GMP) providing strategic and operational QA oversight for product development from early development through commercialization, ensuring compliance with global GMP and supporting DS/DP/FP development, scale-up, and technology transfer.
Responsibilities
- Lead a compliant, phase-appropriate GMP quality culture across development/technical operations.
- Provide QA oversight across product lifecycle activities (DS/DP/FP) from early stage through commercialization.
- Oversee GMP quality systems: deviations, CAPAs, change control, investigations, product complaints.
- Support clinical manufacturing: batch record review/disposition and release of DS/DP/FP for clinical use.
- Ensure quality oversight of process development, tech transfer, scale-up, and validation.
- Prepare/review/approve CMC sections for IND/NDA/MAA and responses to regulatory questions.
- Support regulatory agencies and GMP inspections (PAIs and general inspections).
- Identify compliance risks and escalate appropriately.
- Oversee GMP vendor management and Quality/Technical Agreements with CMOs/partners.
- Support new product intro/integration, stability programs, QMR/APR/APQR quality metrics, and inspection readiness.
- Build/mentor/lead the Development Quality team and champion quality culture.
Qualifications
- BS in scientific discipline; MS/PhD preferred.
- 15+ years pharma/biotech; 12+ years GMP Quality Assurance.
- Deep knowledge of global GMP (FDA, EMA/EudraLex), ICH, and CGMP regulations.
- Experience with CMC, process validation, tech transfer, clinical manufacturing, IND/NDA/MAA, PAIs, vendor oversight, leadership, supply chain lifecycle management, inspection readiness, and continuous improvement.
Compensation
- Salary range: $275,657 to $310,847 USD (base salary only).