Manager - Quality Assurance, Operations
Core
Lead QA Operations for a biomanufacturing facility, overseeing process technology transfer, batch execution, product disposition, and shipping to ensure GMP compliance.
Role type
Manager, Quality Assurance Operations
Builds
Biologics products via advanced mammalian cell line engineering and biomanufacturing
Domain
Biopharma / Biologics / Contract Development and Manufacturing (CDMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP operations leadership, process technology transfer, master batch record review, product disposition, shipping oversight, change control management, audit readiness, CAPA implementation, team recruitment and development, regulatory strategy
Preferred skills
Catalent internal leadership program experience (NGGL, GOLD, LEAD Now, GM Excellence, GROW)
Technologies
single-use systems, GMP facilities
Responsibilities
Lead, coach, and develop team members; ensure compliant execution of CGMP and QMS requirements; serve as primary Quality interface with clients; ensure adequate Quality resources for GMP operations; oversee change control and audit responses; champion continuous improvement initiatives
Seniority
Manager, hands-on leadership
