Director, QC Product Readiness

Regulatory Jobs; Foster City (CA); On-site; USD 210,000 - 272,000; Full time

Job summary

Gilead Sciences, Inc. is seeking a Director, Quality Control Product Readiness to lead the QC Leads responsible for commercial products.

You will set direction, governance, and priorities to ensure product readiness and regulatory lifecycle oversight across analytic activities. The role requires coaching and developing the QC Leads, resolving cross‑program issues, and partnering with cross‑functional teams to ensure compliant post‑approval changes and robust health authority responses.

Qualifications

• BS degree with 12+ years of relevant experience in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or related field.
• MS degree with 10+ years of relevant experience in the same fields.
• PhD with 2+ years of relevant experience in the same fields.
• Experience in pharmaceutical QC including commercialization, lifecycle management, or external laboratory oversight.
• Lead and develop product-focused QC Leads; governance and operating standards.
• Knowledge of analytical method validation, transfer, specifications and data integrity.
• Experience with BLA/NDA content and health authority responses.
• Strong knowledge of cGMP and global regulatory requirements.

Responsibilities

• Oversee clinical-to-commercial QC transitions and product readiness.
• Manage portfolio priorities, testing capacity, resources, and risks.
• Provide technical guidance for analytical issues and readiness gaps.
• Ensure health authority responses and governance of post-approval changes.
• Build and develop a high-performing QC Leads team.
• Define operating model, roles, and development pathways.
• Contribute to strategy, budgeting, and long-range capability development.

Skills

Quality leadership

QC oversight

cGMP knowledge

Regulatory documentation

Method validation

Cross-functional leadership

Communication skills

Education

BS in Chemistry

MS in Pharmaceutical Sciences

PhD in Life Sciences

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 the 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

Company Overview

Gilead Sciences, Inc. is a biopharmaceutical company committed to advancing innovative medicines that help prevent and treat life‑threatening diseases. Our work is grounded in scientific rigor, collaboration, accountability, and a shared commitment to improving the lives of patients.

Position Overview

The Director, Quality Control Product Readiness leads the organization of QC Leads responsible for assigned commercial products and programs. The role establishes direction, governance, expectations, and resource priorities for the QC Lead function, ensuring consistent oversight of product readiness, analytical lifecycle activities, and transition from clinical to commercial QC. This leader coaches and develops the QC Leads, removes barriers, resolves cross-program issues, and serves as the escalation point in commercial QC.

Focus Areas

Product Readiness and Portfolio Execution

• Oversee clinical-to-commercial QC transitions and ongoing product readiness, ensuring clear criteria, stakeholder alignment, sustainable ownership, and resolution of readiness gaps.


• Manage portfolio priorities, testing capacity, resources, and execution risks; ...


• Analytical and Regulatory Lifecycle Oversight


• Provide technical guidance and decision frameworks for complex analytical issues, investigations, methods, specifications, reference standards, documentation, and related readiness gaps.


• Ensure scientifically sound health authority responses and governance of post-approval changes and regulatory commitments through implementation and closure.

Leadership and Cross-Functional Partnership

• Build, lead, mentor, and develop a high‑performing team of QC Leads responsible for product readiness and analytical lifecycle oversight.


• Define the QC Lead operating model, role expectations, decision rights, performance standards, and development pathways.


• Ensure appropriate assignment and capacity of QC Leads across the portfolio based on program complexity, risk, and business priorities.


• Establish scalable standards, metrics, and continuous improvement practices that strengthen consistency, product readiness, compliance, and execution across the QC Lead organization.


• Contribute to department strategy, workforce and resource planning, budgeting, succession planning, and long‑range capability development.

Qualifications

• BS degree with 12+ years of relevant experience, MS degree with 10+ years of relevant experience, or PhD with 2+ years of relevant experience in Chemistry, Biochemistry, Pharmaceutical Sciences, Life Sciences, or a related field.


• Significant experience in pharmaceutical or biopharmaceutical Quality Control, including leadership of technical professionals responsible for commercialization, product lifecycle management, or external laboratory oversight.


• Demonstrated ability to lead and develop product-focused QC Leads, establish governance and operating standards, balance portfolio priorities, and drive accountability through others.


• Broad technical knowledge of analytical method validation and transfer, method lifecycle management, commercial specifications, laboratory investigations, sample management, and testing logistics.


• Experience providing leadership oversight for QC-related BLA or NDA content and responses to health authority questions.


• Strong knowledge of cGMP principles, data integrity expectations, and applicable global regulatory requirements for commercial analytical testing.


• Proven ability to influence senior cross-functional stakeholders, resolve complex escalations, manage competing portfolio priorities, and make risk-based decisions in ambiguous environments.


• Excellent scientific judgment, people leadership, coaching, organizational, written communication, and presentation skills.

The salary range for this position is: $210,375.00 - $272,250.00. 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.

For jobs in the United States:

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] for assistance.

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

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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.