Head of Validation - Manufacturing

Gilead Sciences seeks an experienced validation leader to establish and oversee the Manufacturing Validation function at its Foster City site. This role will build a risk-based validation program for a new biologics facility and lead the existing validation team supporting clinical manufacturing and warehouse operations.

Responsibilities

• Develop and implement an integrated, risk-based validation strategy and governance model for facilities, utilities, equipment, automation, and computer systems
• Lead validation activities from design and construction through commissioning, qualification, and transition to routine GMP operations
• Apply science- and risk-based principles to focus testing and documentation on critical aspects while maintaining traceability to patient and product safety
• Provide leadership and coaching for existing and new validation department employees and support career growth
• Establish standards, procedures, and decision forums; define roles across internal teams, vendors, and contractors; and ensure inspection readiness

Requirements

• Master's degree with 8+ years relevant experience, or Bachelor's with 10+ years in biopharmaceutical validation
• Demonstrated leadership of validation for startup and licensure of a biotech or biologics manufacturing facility
• Significant experience designing and implementing risk-based, lifecycle validation approaches in GMP-regulated environments
• Deep technical knowledge of facility, utility, equipment qualification, and computer system validation with regulatory awareness
• Proven ability to build validation organizations, establish governance, and lead cross-functional teams through complex programs
• Strong cross-functional communication and decision-making skills with unwavering commitment to quality and cGMP compliance

Compensation: $182,070–$235,620 base