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.

• Execute GMP batch disposition and release for active pharmaceutical ingredients (APIs) and intermediates to ensure timely, compliant, well‑documented release decisions supporting commercial supply.
• Review and disposition API batch records, CoFA and quality documentation from external CMOs/CDMOs against approved specifications and the Quality Management System.
• Coordinate resolution of release‑blocking deviations, OOS/OOT investigations, and documentation gaps with manufacturing partners and internal stakeholders.
• Maintain accurate, inspection‑ready release records and contribute to cycle‑time and right‑first‑time improvements for the API release workflow.
• Operate with documentation rigor, traceable decision rationales, and clear escalation discipline.
• 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 coordination across MSAT, Supply Chain, and Regulatory for release priorities.
• Veeva Vault Quality (eQMS) proficiency to execute batch disposition workflows and maintain inspection‑ready records.

We are committed to fostering an inclusive and diverse workplace and do not discriminate on the basis of any legally protected characteristics. Madrigal processes your personal data in connection with its recruitment and talent sourcing activities in accordance with applicable data protection laws. Further information about how your personal…