Head of Validation - Manufacturing

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

Required Skills:

• 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, with an unwavering commitment to quality, data integrity, cGMP compliance, and patient safety.

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.

The ideal candidate would also have:

…