Senior Manager, QA Shopfloor Lead
Core
Senior Manager leading the QA Shopfloor program to ensure GMP compliance, real-time batch record review, and quality oversight of manufacturing operations at a Cell Therapy facility.
Role type
Senior Manager, Quality Assurance Operations
Builds
GMP-compliant cell therapy manufacturing processes and quality systems
Domain
Life Sciences / Cell Therapy Manufacturing
Required skills
GMP compliance, batch record review, deviation/CAPA management, risk assessment, team leadership, cross-functional collaboration, inspection readiness, process validation
Preferred skills
Engineering or life science degree, experience in cell therapy manufacturing, matrixed environment leadership
Technologies
GMP systems, digital batch record tools, quality management systems
Responsibilities
Lead QA Shopfloor program and act as deputy to Associate Director; drive continuous improvement in quality processes; represent QA in cross-site projects; lead inspection readiness activities; monitor team compliance and performance; provide oversight of GMP operations and resolve quality events; support change control and deviation investigations; mentor QA personnel.
Seniority
Senior Manager, strategic leadership with hands-on operational oversight