Manager / Senior Manager, Quality Assurance
Core
Own batch disposition and product complaint management for products made at contract manufacturing organizations (CMOs) to ensure cGMP and regulatory compliance.
Role type
Manager / Senior Manager Quality Assurance (Pharmaceuticals)
Builds
Commercial pharmaceutical and combination product lots
Domain
Pharmaceuticals / Quality Assurance
Required skills
Batch record review, lot disposition, deviation management, root cause analysis, CAPA management, CMO oversight, regulatory compliance (cGMP), SOP authoring, risk assessment
Preferred skills
Drug-device combination product experience, sterile/nasal/inhalation dosage forms, Electronic QMS (Veeva, MasterControl), ASQ certification (CQA/CQE/CPGP)
Technologies
Veeva Vault QualityDocs/QMS, MasterControl
Responsibilities
Review executed batch records and certificates of analysis from CMOs; manage product complaint intake, triage, and closure; lead root cause investigations and CAPA effectiveness; oversee CMO quality agreements and audits; author SOPs for batch disposition and complaints; track batch release timelines.
Seniority
Manager / Senior Manager, hands-on IC
