Associate Director, API Quality Assurance (GMP)
About The Position
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Leads GMP API Quality Assurance to ensure compliant, risk-based oversight of active pharmaceutical ingredient (API) and intermediate manufacturing across external CMOs/CDMOs. Owns API-specific quality strategy, governance cadence, and performance management to enable predictable supply and consistent compliance with ICH Q7 and global health authority expectations. Establishes standards for API batch documentation review, deviation and change control management, and partner performance trending. Partners with MSAT, Supply Chain, Regulatory, and CMOs on tech transfer readiness, control strategy evolution, and lifecycle management of commercial APIs. Maintains inspection readiness through robust documentation control, evidence packages, and decision rationale traceability.
Requirements
- BS or MSc in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, or related)
- 10-12 years of GMP pharmaceutical/biotech experience with significant focus on API quality and CMO oversight
- Demonstrated leadership in API batch disposition, deviation/CAPA, and change control governance
- Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations
- Proven track record managing external API manufacturers and supporting health authority inspections
Nice To Haves
- Advanced degree (MS/PhD) and experience with small molecule API and/or oligonucleotide manufacturing
- Experience supporting tech transfers, validation, and post-approval change management at API CMOs
- Experience with Veeva Vault Quality (eQMS) and quality metrics/trending for API operations
- Experience in pharmaceutical / biotech external manufacturing networks (preferred)
Responsibilities
- Own GMP API Quality Assurance strategy, governance cadence, and standards across external API manufacturers
- Lead quality oversight of API and intermediate manufacturing at CMOs/CDMOs, ensuring ICH Q7 and global GMP compliance
- Set expectations for API batch record review quality, documentation rigor, and decision rationale traceability
- Drive deviation impact assessment, RCA rigor, CAPA linkage, and effectiveness verification for API quality events
- Oversee change control review and approval for API processes, specifications, methods, and partner-initiated changes
- Maintain quality agreements with API CMOs and lead performance governance routines (KPIs, scorecards, QBRs)
- Partner with MSAT/CMC on API control strategy evolution, validation readiness, and tech transfer to/from partners
- Ensure quality oversight across the API lifecycle, including PPQ, routine manufacturing, and post-approval changes
- Lead inspection readiness for API operations, including documentation, evidence packages, and audit response narratives
- Support FDA, EMA, and other health authority inspections related to API manufacturing and partner audits
- Drive trending and recurrence prevention for API quality events; deliver management review-ready insights
- Lead and mentor API QA staff and provide quality input on cross-functional governance forums
Benefits
- flexible paid time off
- medical
- dental
- vision
- life/disability insurance
- 401(k) offerings (i.e., traditional, Roth, and employer match)
- supplemental life insurance
- legal services
- mental health benefits through our Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
