Manager, GMP API Quality Release

Madrigal, a biopharmaceutical firm dedicated to creating new treatments for metabolic dysfunction‑associated steatohepatitis, seeks a Manager to lead GMP API Quality Release. The position supports commercial supply by ensuring that active pharmaceutical ingredient batches and intermediates are released on time, compliantly and with full documentation. The role involves reviewing and disposing of GMP batch records, certificates of analysis and related quality files from external CMOs or CDMOs, confirming they meet approved specifications, methods and the company’s Quality Management System. The manager coordinates the resolution of release‑blocking deviations, out‑of‑specification or out‑of‑trend findings, and any documentation gaps, while maintaining inspection‑ready records, tracking cycle‑time metrics and driving right‑first‑time improvements. Interaction with MSAT, Supply Chain, Regulatory and manufacturing partners is required to prioritize releases and support change controls. Candidates must hold a bachelor’s degree in a scientific discipline and possess five to seven years of GMP pharmaceutical or biotech experience, including hands‑on batch record review and disposition of API documentation. A solid grasp of GMP, ICH Q7 and FDA/EMA expectations is essential. Preferred experience includes work with small‑molecule or oligonucleotide APIs, use of Veeva Vault Quality for batch workflows, and participation in health‑authority inspections or deviation investigations. Madrigal emphasizes an inclusive, high‑performing culture that values scientific rigor and collaborative problem‑solving.