Manager, Quality Assurance Operations
Core
Manager of Quality Assurance Operations supporting day-to-day GMP QA activities for manufacturing, testing, and release of iPBMCs in a cell therapy facility.
Role type
Manager, Quality Assurance Operations (cGMP)
Builds
Qualified cell therapy lots (iPBMCs) for clinical and commercial use
Domain
Biopharmaceuticals / Cell Therapy / cGMP Manufacturing
Required skills
cGMP compliance, batch record review, deviation/CAPA management, SOP authoring, team leadership, regulatory inspection support, electronic QMS proficiency, technical writing, change control, validation oversight
Preferred skills
Cell culture experience, development initiative leadership, mentoring, performance management, complex manufacturing environment navigation
Technologies
Electronic QMS, Microsoft Office Suite (Word, Excel, PowerPoint)
Responsibilities
Review and approve qualification/validation protocols and batch records; manage internal QA team and performance reviews; interact with CMOs for batch release; author and revise SOPs and quality documentation; support internal audits and regulatory inspections; ensure efficient QA operations and compliance with cGMPs and safety regulations.
Seniority
Manager, hands-on leadership