Senior GMP API Quality Release Manager

Madrigalpharma; Schweiz; Vor Ort; EUR 129.757 - 173.009; Vollzeit

Zusammenfassung

Madrigal is seeking a Manager, GMP API Quality Release for its Zug, Switzerland operations. You will execute GMP batch disposition and release for APIs and intermediates to support commercial supply, with rigorous documentation and escalation as needed.

Responsibilities include reviewing batch records, cofAs, and QA documentation; coordinating deviations with CMOs/CDMOs; owning the Veeva-based disposition workflow; and driving cycle-time improvements with MSAT, Supply Chain, and Regulatory

Qualifikationen

• BS in a scientific discipline (Chemistry, Chemical Engineering, Pharmacy, Life Sciences, or related).
• 5–7 years of GMP pharmaceutical/biotech experience including batch record review and disposition.
• 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.
• Excellent documentation discipline and risk-based judgment.

Aufgaben

• Review and disposition GMP batch records, CofAs, executed batch documentation, and release packages for API and intermediates.
• Coordinate timely resolution of release-blocking deviations, OOS/OOT results, and documentation gaps with CMOs/CDMOs.
• Own and execute the API Batch Disposition workflow within Veeva Vault Quality; maintain inspection-ready records.
• Track API release cycle time, backlog, and RFT metrics; drive right-first-time improvements with partners.
• Support change controls impacting API release with timely assessment and audit-ready evidence.

Kenntnisse

Batch record review

Disposition discipline

Risk-based judgment

Cross-functional coordination

Inspection readiness

Ausbildung

BS in scientific discipline

Tools

Veeva Vault Quality

Jobbeschreibung

Madrigal is seeking a Manager, GMP API Quality Release for its Zug, Switzerland operations. You will execute GMP batch disposition and release for APIs and intermediates to support commercial supply, with rigorous documentation and escalation as needed.

Responsibilities include reviewing batch records, cofAs, and QA documentation; coordinating deviations with CMOs/CDMOs; owning the Veeva-based disposition workflow; and driving cycle-time improvements with MSAT, Supply Chain, and Regulatory