Head of Validation - Manufacturing
Core
Lead the Manufacturing Validation function to establish and execute an integrated, risk-based validation program for a new biologics facility, utilities, equipment, and computerized systems.
Role type
Senior IC validation leader (manufacturing)
Builds
A compliant, inspection-ready biologics manufacturing facility and its supporting systems
Domain
Biopharmaceutical manufacturing / GMP / Facility startup
Required skills
Risk-based validation, lifecycle validation, facility qualification, utility qualification, equipment qualification, computer system validation, GMP compliance, team leadership, cross-functional influence
Preferred skills
Startup of new biotech/biologics facilities, strategic thinking, status quo challenge
Technologies
GMP, cGMP, validation frameworks, automation platforms
Responsibilities
Establish site validation strategy and governance; Lead validation through facility startup from design to routine operations; Implement risk-based validation principles; Build a high-performing validation department; Build governance and execution capability; Drive inspection readiness and sustainable operations
Seniority
Senior, hands-on IC