Manager, GMP API Quality Release

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.

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.

Executes GMP batch disposition and release for active pharmaceutical ingredients (APIs) and intermediates to ensure timely, compliant, well‑documented release decisions supporting commercial supply. Reviews and dispositions API batch records, Cof As, and supporting quality documentation from external CMOs/CDMOs against approved specifications and the Quality Management System.

Coordinates resolution of release‑blocking deviations, OOS/OOT investigations, and documentation gaps with manufacturing partners and internal stakeholders. Maintains accurate, inspection‑ready release records and contributes to cycle‑time and right‑first‑time improvements for the API release workflow. Operates with documentation rigor, traceable decision rationales, and clear escalation discipline.

• Review and disposition GMP batch records, Cof As, executed batch documentation, and release packages for API and intermediates
• Verify conformance to approved specifications, methods, control strategy, and the Quality Management System
• Coordinate timely resolution of release‑blocking deviations, OOS/OOT results, and documentation gaps with CMOs/CDMOs
• Assess impact of deviations and quality events on API batch disposition and document risk‑based release decisions
• Own and execute the API Batch Disposition workflow within Veeva, ensuring complete and inspection‑ready records
• Track and report API release cycle time, backlog, and RFT metrics; drive right‑first‑time improvements with partners
• Partner with MSAT, Supply Chain, and Regulatory on release priorities, supply continuity, and timeline mitigation
• Support change controls impacting API release (specifications, methods, supplier changes) with timely assessment
• Maintain inspection‑ready release evidence packages and support audit/inspection responses for API operations
• Escalate quality concerns, recurring documentation errors, or supply‑impacting risks with clear options and rationale
• Contribute to SOPs, work instructions, and release checklists for API disposition processes
• Support continuous improvement of release workflows and partner documentation quality

• BS in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related)
• 5–7 years of GMP pharmaceutical/biotech experience including hands‑on batch record review and disposition
• Demonstrated experience reviewing API or drug product batch documentation from external CMOs
• Strong knowledge of GMP requirements, ICH Q7, and FDA/EMA expectations for batch release
• Strong documentation discipline, attention to detail, and risk‑based judgment

• Experience with API and intermediate disposition, including small molecule and/or oligonucleotide manufacturing
• Experience with Veeva Vault Quality (eQMS) batch disposition workflow
• Experience supporting health authority inspections with batch disposition narratives and evidence
• Experience reviewing deviation and OOS/OOT investigations

• Batch record review and disposition discipline, documentation rigor, and decision rationale traceability
• Risk‑based judgment for release decisions, deviation impact assessment, and escalation discipline
• Partner coordination with external CMOs for documentation quality and timely issue resolution
• Cycle‑time and right‑first‑time focus, backlog management, and metrics‑driven execution
• Inspection readiness mindset, evidence retrieval readiness, and audit narrative support
• Cross‑functional…