Associate Director, Development Quality – OSD
About the role
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. 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).
Provides modality‑focused development QA leadership for oral programs, ensuring phase‑appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program‑level quality strategy, governance cadence, and readiness milestones and ensures development documentation is traceable and inspection‑ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management. Supports efficient progression toward commercialization while maintaining compliance and predictable execution.
Responsibilities
- Own quality strategy, governance cadence, and risk register for assigned oral programs, define and track readiness milestones
- Guide application of QMS processes (deviations / CAPA / change control) in development context and ensure timely closure
- Produce deliverables such as program quality plans, readiness trackers, and decision / action logs
- Oversee external vendors / CMOs supporting oral development activities as applicable, ensure governance and escalation pathways
- Maintain inspection‑ready documentation, narratives, and evidence packages for program scope
- Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes
Requirements
- BS+ Life Sciences / Engineering (or related)
- 10–12 years QA experience with development‑stage oversight