Validation Manager
Core
Manage validation activities to ensure product quality and regulatory compliance for therapeutics manufacturing.
Role type
Validation Manager
Builds
Validated state of systems, equipment, utilities, facilities, and manufacturing processes
Domain
Pharmaceutical/Biotech manufacturing
Required skills
cGMP regulations (FDA/EU), risk assessment methodologies, statistical analysis, validation master planning, change control systems, regulatory inspection participation, equipment/process/utility validation, people management, technical writing
Preferred skills
smoke studies experience, lean/continuous improvement methodologies, advanced degree
Technologies
standard business software applications
Responsibilities
Develop validation strategy, oversee team qualifying equipment/utilities/facilities/computer systems/manufacturing processes, align validation with cGMP requirements, support new product introductions and technology transfers
Seniority
Mid-Senior, hands-on IC with team leadership