Validation Manager
Core
Manage validation activities to ensure product quality and regulatory compliance in pharmaceutical/biotech manufacturing.
Role type
Senior IC Validation Manager
Builds
Validated state of equipment, utilities, facilities, computer systems, and manufacturing processes
Domain
Pharmaceutical/Biotech Manufacturing
Required skills
cGMP compliance, validation strategy development, team leadership, equipment/process/utility validation, data integrity (ALCOA++), regulatory inspection participation, validation master planning, change control, risk assessment, statistical analysis
Preferred skills
Temperature mapping, lean/continuous improvement methodologies
Technologies
Standard business software applications
Responsibilities
Develop validation strategy, oversee team qualifying equipment/utilities/facilities/systems/processes, ensure alignment with cGMP for new product introductions and technology transfers, participate in regulatory inspections and customer audits
Seniority
Senior, hands-on IC with people management
