Associate Director, API Quality Assurance (GMP)
Madrigal Pharmaceuticals · Remote
QualityRemoteFull-time$169k–$198kCompany career page
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Role summary
Madrigal Pharmaceuticals seeks an Associate Director of API Quality Assurance to lead GMP oversight of active pharmaceutical ingredient manufacturing at external partners. This role establishes quality strategy, governance frameworks, and compliance standards while managing CMO relationships and supporting regulatory inspections.
What they're looking for
- BS or MSc in Chemistry, Chemical Engineering, Pharmacy, or related discipline
- 10-12 years GMP pharmaceutical or biotech experience with API quality focus
- Demonstrated leadership in API batch disposition, deviation, CAPA, and change control
- Strong knowledge of ICH Q7, Q8-Q11, FDA, and EMA regulatory expectations
- Proven track record managing external API manufacturers and health authority inspections
- Veeva Vault Quality (eQMS) proficiency preferred
- Experience with small molecule or oligonucleotide API manufacturing preferred
What you'll be doing
- Establish and own GMP API quality strategy, governance cadence, and compliance standards across external manufacturers
- Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs for ICH Q7 and global GMP compliance
- Drive deviation assessment, root cause analysis rigor, CAPA linkage, and effectiveness verification for quality events
- Oversee change control review and approval for API processes, specifications, and partner-initiated changes
- Maintain quality agreements with API CMOs and lead performance governance including KPIs and quality business reviews
Privacy & handoff
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