Head of Validation - Manufacturing
Gilead Sciences
Summary
Gilead Sciences is seeking an experienced validation leader to head the Manufacturing Validation function at the Foster City site. This role will establish and lead an integrated, risk-based validation program for the facilities, utilities, equipment, automation, and computerized systems supporting a new state-of-the-art biologics facility. In partnership with Engineering, Manufacturing, Quality, Automation, IT, and project teams, this leader will define the validation framework, build the capabilities required for execution, and ensure the new facility is compliant and inspection-ready from startup through routine operations. The successful candidate will also lead and integrate the existing validation team supporting the site's small-molecule clinical manufacturing pilot plants and warehouse.
Job description
Job Responsibilities
- Establish the site validation strategy: Develop and implement an integrated, risk-based validation strategy, governance, acceptance criteria, and oversight model for facilities, utilities, process equipment, automation platforms, and GMP computer systems supporting the new Foster City biologics facility.
- Lead validation through facility startup: Provide site validation leadership and oversight from design and construction through commissioning, qualification, process readiness, and transition to routine GMP operations in alignment with the overall project schedule.
- Implement risk-based validation: Apply science- and risk-based principles to focus testing and documentation on critical aspects, leverage supplier and commissioning evidence where appropriate, and maintain clear traceability to patient, product, and data-integrity risks.
- Build a high performing validation department: Provide leadership guidance and coaching for existing and new validation department employees, forecast and manage workload, and support employee career growth.
- Build governance and execution capability: Establish standards, procedures, templates, metrics, and decision forums; define roles across internal teams, engineering partners, vendors, and contractors; and develop a high-performing validation organization sized for each phase of the program.
- Drive inspection readiness and sustainable operations: Partner with Quality and system owners to ensure the new biologics facility and existing small molecule facilities are inspection-ready, including validation ownership, periodic review, change control, requalification, maintenance of the validated state, and continual improvement.
Qualifications
- Requires a Masters degree with 8+ years of relevant professional experience, or BS with 10+ years of relevant professional experience – a degree in a relevant scientific or business discipline is strongly preferred.
- Hands-on experience implementing risk-based validation in a biopharmaceutical manufacturing environment.
- Excellent organizational and communication (both written and verbal) skills.
- Demonstrated experience leading and engaging a team of technical experts.
Ideal Candidate
- Significant experience with facility, equipment and utility qualification for startup of a manufacturing facility.
- Significant experience with computerized system validation in a biopharmaceutical environment.
- Strategic thinking and ability to influence and constructively challenge the status quo.
Requirements
- Demonstrated leadership of validation for the startup and licensure of a new biotech or biologics manufacturing facility
- Significant experience designing and implementing risk-based, lifecycle validation approaches in a GMP-regulated environment
- Deep technical knowledge of facility, utility and equipment qualification and computer system validation, including applicable regulatory expectations and industry standards
- Proven ability to build validation organizations and governance, establish clear accountabilities, and lead employees, contractors, and partner functions through complex startup programs
- Strong cross-functional influence, decision-making, and communication skills
- Unwavering commitment to quality, data integrity, cGMP compliance, and patient safety
- Masters degree with 8+ years of relevant professional experience, or BS with 10+ years of relevant professional experience
- Hands-on experience implementing risk-based validation in a biopharmaceutical manufacturing environment
- Excellent organizational and communication (both written and verbal) skills
- Demonstrated experience leading and engaging a team of technical experts
Benefits
- Medical, Dental & Vision
- Life Insurance
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
Company overview
Gilead Sciences, Inc. is a leading American biopharmaceutical company headquartered in Foster City, California, that specializes in researching, developing, and commercializing innovative medicines for life-threatening diseases. Founded in 1987, Gilead has grown into a global healthcare leader with approximately 17,600 employees worldwide. The company's primary therapeutic focus areas include HIV/AIDS, viral hepatitis (hepatitis B and C), oncology, inflammation, and respiratory diseases. Gilead is renowned for its groundbreaking antiviral therapies, including Sovaldi and Harvoni for hepatitis C, and its comprehensive portfolio of HIV treatments such as Truvada, Atripla, and Biktarvy. The company also developed Veklury (remdesivir) for COVID-19 treatment. Gilead operates as a publicly traded company on the NASDAQ (GILD) and is a component of both the Nasdaq-100 and S&P 100 indices. Through strategic acquisitions like Kite Pharma and Immunomedics, Gilead has expanded into cell therapy and oncology, demonstrating its commitment to advancing medical science and improving patient outcomes globally.