Manager, GMP API Quality Release
On-siteZug, Zug, Switzerland
Job Summary
Execute GMP batch disposition and release for active pharmaceutical ingredients and intermediates by reviewing batch records, CofAs, and external CMO documentation against approved specifications and the Quality Management System. Coordinate resolution of release-blocking deviations, OOS/OOT investigations, and documentation gaps with manufacturing partners while maintaining accurate, inspection-ready records. Own the API Batch Disposition workflow within Veeva, track cycle-time metrics, and drive right-first-time improvements with Supply Chain and Regulatory teams. Support change controls and audit responses to ensure supply continuity and compliance.
Required Qualifications
- 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
- Applicants must be authorized to work in the country of employment at the time of application
Desired Qualifications
- 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
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