Head of Validation - Manufacturing

Regulatory Toolkit; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid time off

Stock-based incentives

Job summary

Gilead Sciences Inc. in Foster City is seeking a senior validation leader to design and drive the startup validation program for a biopharmaceutical facility. You will guide governance, risk-based validation, and system qualification to ensure patient safety and data integrity.

The role requires advanced degrees or equivalent experience, strong leadership, and cross-functional collaboration to manage complex startup programs and sustain inspection-ready operations.

Qualifications

• 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 skills.
• Demonstrated experience leading and engaging a team of technical experts.

Responsibilities

• Establish site validation strategy for facilities, utilities, equipment, automation, and GMP computer systems.
• Lead validation through startup, commissioning, qualification, and transition to routine GMP operations.
• Apply risk-based validation principles to focus testing and maintain traceability to patient and product risks.
• Provide leadership coaching, forecast workload, and support career growth within the validation team.
• Establish standards, templates, metrics, and governance across engineering partners and contractors.
• Drive inspection readiness and ensure ongoing validation ownership and change control.

Skills

Validation leadership

GMP compliance

Cross-functional influence

Quality/data integrity

People management

Education

Masters degree +8 years

BS +10 years

Job description

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

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:

• 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.

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [e-mail] assistance.

For more information about equal employment opportunity protections, please view the'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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