Manager, GMP API Quality Release
Core
Executes GMP batch disposition and release for active pharmaceutical ingredients (APIs) and intermediates to ensure timely, compliant, well-documented release decisions supporting commercial supply.
Role type
Manager, GMP API Quality Release
Builds
Commercial supply of APIs and intermediates
Domain
Biopharmaceuticals / Small molecule and oligonucleotide manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP batch record review and disposition, ICH Q7 knowledge, FDA/EMA batch release expectations, deviation impact assessment, OOS/OOT investigation review, Veeva Vault Quality (eQMS) workflow execution, risk-based judgment, CMO/CDMO coordination
Preferred skills
API and intermediate disposition (small molecule/oligonucleotide), health authority inspection support, change control assessment for API release
Technologies
Veeva Vault Quality (eQMS)
Responsibilities
Review and disposition GMP batch records, CofAs, and release packages for API and intermediates; Verify conformance to approved specifications, methods, control strategy, and the Quality Management System; Coordinate timely resolution of release-blocking deviations, OOS/OOT results, and documentation gaps with CMOs/CDMOs; Assess impact of deviations and quality events on API batch disposition and document risk-based release decisions; Own and execute the API Batch Disposition workflow within Veeva, ensuring complete and inspection-ready records; Track and report API release cycle time, backlog, and RFT metrics; Partner with MSAT, Supply Chain, and Regulatory on release priorities, supply continuity, and timeline mitigation; Support change controls impacting API release with timely assessment; Maintain inspection-ready release evidence packages and support audit/inspection responses; 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
Seniority
Manager, operational execution and partner coordination