Associate Director, GMP Quality Release (Quality API)
Core
Leads batch review and release operations for Active Pharmaceutical Ingredients (API) and intermediates, ensuring compliant disposition and supply continuity for commercial portfolios.
Role type
Senior IC Quality Release Lead (API)
Builds
Compliant commercial API supply chain
Domain
Biopharmaceuticals / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP batch disposition leadership, API release governance, deviation impact assessment, CMO/CDMO partner management, risk-based release judgment, inspection readiness documentation, cycle-time optimization, SOP development, team mentorship, Veeva Vault Quality proficiency
Preferred skills
Drug product (DP) release expertise, virtual/outsourced manufacturing model experience, health authority inspection support, cross-functional executive communication
Technologies
Veeva Vault Quality (eQMS)
Responsibilities
Own batch review standards and decision rights for API/intermediates; Lead disposition of commercial API batches; Drive cycle-time and backlog management; Establish escalation pathways for release exceptions; Coordinate resolution of release-blocking deviations; Assess deviation impact on batch disposition; Govern Batch Disposition process in Veeva; Partner with MSAT, Supply Chain, and Regulatory on release priorities; Maintain inspection-ready evidence packages; Lead and mentor batch review staff; Contribute to SOPs and workflow improvements
Seniority
Senior, hands-on IC with leadership responsibilities