Senior Manager C&Q
Core
Senior Manager leading Qualification and Validation (C&Q) activities for laboratory equipment, utilities, HVAC, and computerized systems at a biologics manufacturing site.
Role type
Senior Manager, Validation/Qualification
Builds
Validated and compliant state of operation for manufacturing systems and equipment
Domain
Biologics manufacturing / Pharmaceutical Engineering
Required skills
Validation/Qualification strategy, IQ/OQ/PQ execution, GxP/FDA/EMA compliance, project management, team leadership, regulatory inspection readiness, risk assessment, change control management, resource management
Preferred skills
Lean principles, distributed control systems (GAMP), financial resource planning, matrix environment leadership
Technologies
CMMS, HVAC systems, Compressed gas systems, Vacuum systems, Computerized systems, Automation systems
Responsibilities
Lead Validation/Qualification function for manufacturing site and QC labs; Manage IQ/OQ/PQ of laboratory equipment and critical utility systems; Oversee validation execution for engineering projects; Own the Site Validation Master Plan; Act as validation SME for Health Authority inspectors; Manage high-performance team and staff development; Ensure GxP compliance and regulatory inspection readiness.
Seniority
Senior, hands-on IC with management responsibilities