Manager - Quality Assurance, Operations
Core
Lead QA Operations team to ensure compliant execution of cGMP and QMS requirements across manufacturing, including process technology transfer, batch execution, and product disposition.
Role type
Senior IC Quality Assurance Manager (Biologics/CDMO)
Builds
Biologics manufacturing operations and quality compliance
Domain
Biopharmaceuticals / Contract Development and Manufacturing Organization (CDMO)
Required skills
GMP operations leadership, team coaching and development, regulatory compliance (cGMP, FDA, EMA), change control management, audit readiness, CAPA implementation, client quality interface, data integrity, cross-functional collaboration
Preferred skills
Catalent leadership program experience (NGGL, GOLD, LEAD Now, GM Excellence, GROW), drug development lifecycle strategy
Technologies
Single-use systems, GMP facilities, QMS software
Responsibilities
Lead, coach, and develop team members; Ensure compliant execution of CGMP and QMS requirements; Serve as primary Quality interface with clients; Oversee change control processes and audit responses; Champion continuous improvement initiatives; Recruit and lead a high-performing Quality team
Seniority
Senior, hands-on IC with leadership responsibilities