Manager, Quality Assurance Second Shift
Core
Direct Shop Floor Quality Assurance (SFQA) team on second shift to support process introduction, compliance, and manufacturing readiness for commercial drug product production.
Role type
Manager, Quality Assurance (Manufacturing)
Builds
Commercial pharmaceutical drug substance and drug product
Domain
Pharmaceutical manufacturing (biotech/cell therapy)
Required skills
cGMP compliance, Aseptic manufacturing, Deviation management, Root Cause Analysis, People leadership, Batch record review, Environmental monitoring, Quality Management Systems (QMS), Critical alarm management, Process observations
Preferred skills
Media fill experience, Biological drug substance expertise, Quality Risk Management, Kneat/Veeva Vault/MEDS/SAP proficiency, RCA with MPS tools, Planning and scheduling
Technologies
SAP, CLUE, Kneat, Veeva Vault, MEDS, Trackwise, GLIMS, Electronic Batch Records (MES)
Responsibilities
Manage SFQA team for second shift; Lead end-to-end QA support for production; Ensure compliance with cGMP and regulations; Support deviation management and investigations; Lead Aseptic Observer Program and Batch Record Review; Foster high-performing culture and coach team members.
Seniority
Manager, direct leadership
