Associate Director, GMP Quality Release (Quality API)

About the role

Madrigal, a biopharmaceutical company developing novel therapeutics for MASH, is hiring an Associate Director, GMP Quality Release (Quality API). The role leads batch review and release operations across API and intermediate manufacturing, with additional support for drug product (DP) release as needed, and owns batch disposition standards, review quality and cycle-time performance.

Key responsibilities

• Own batch review and release standards, decision rights and checklists for API and intermediates, with DP cross-coverage
• Lead disposition of commercial API and intermediate batches and drive cycle-time, backlog and right-first-time performance
• Set escalation pathways for release exceptions, OOS/OOT results and deviation-impacted batches
• Coordinate resolution of release-blocking deviations, investigations and documentation gaps with CMOs/CDMOs, and assess their impact on batch disposition
• Govern the Batch Disposition process in Veeva, keeping records inspection ready
• Support release priorities, supply continuity and timelines with MSAT, Supply Chain and Regulatory, and support health authority inspections
• Mentor batch review and release staff and provide cross-coverage between API and DP release

Required profile

• BS or MSc in Chemistry, Chemical Engineering, Pharmacy, Life Sciences or a related field
• 10-12 years of GMP pharmaceutical/biotech experience, including significant batch disposition/release leadership
• Demonstrated API batch review and release experience with working knowledge of DP release
• Proven track record managing batch release at external CMOs and improving release cycle time
• Authorized to work in the country of employment

Required skills

• Strong knowledge of ICH Q7, ICH Q8-Q10, FDA, EMA and global GMP batch release expectations
• Preferred: hands-on API and DP disposition, Veeva Vault Quality (eQMS) batch disposition, and experience supporting health authority inspections