Director, Analytical Quality Assurance

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

Benefits offered by this job

Medical insurance

401(k) plan

Bonus eligibility

Job summary

Gilead Sciences, Inc. in Foster City, CA is seeking a senior leader to oversee analytical quality for external QC labs and stability programs. You will ensure compliance with cGMP and regulatory requirements, review critical quality documents, and drive CAPA efforts.

The role leads the Analytical Quality Assurance team, partnering with Manufacturing and external partners to support lifecycle priorities and regulatory readiness.

Qualifications

• Bachelor's or higher in chemistry or a related field.
• 12+ years in pharmaceutical quality/QA with progressive leadership.
• Experience with GMP/cGMP, ICH, FDA/EMA regulatory expectations.
• Proven ability to review data, investigations and risk-based decisions.

Responsibilities

• Lead analytical quality oversight for external QC labs and stability programs.
• Review and approve quality documents (SOPs, specs, methods, reports, CAPAs).
• Ensure analytical testing complies with regulatory requirements (FDA/EMA, cGMP).
• Oversee investigations related to OOS/OOT and CAPA recommendations.
• Provide quality governance for contract partners and testing labs.
• Maintain and improve CAPA, change control, risk management, and QA systems.
• Manage audits/inspections and internal QA processes.
• Review NDA/CMC filings' analytical data with cross-functional teams.
• Lead and develop the Analytical Quality Assurance team.

Skills

Quality oversight

Leadership

Regulatory knowledge

Analytical quality

Communication

Education

BS in chemistry

MS in chemistry

PhD in chemistry

Tools

LIMS

SOP software

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

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Key Responsibilities

Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring activities, investigations, documentation, and quality decisions are scientifically sound, risk-based, and compliant with applicable regulatory requirements.

Provide quality governance for contract partners and testing laboratories, partner cross-functionally with Manufacturing, and external partners to support product lifecycle and regulatory priorities, and lead the Analytical Quality Assurance team while fostering accountability, collaboration, and a strong quality culture.

Job Responsibilities

• Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
• Review and approve analytical quality documents, including SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, and quality assessments.
• Ensure analytical testing activities comply with applicable quality objectives, cGMP, GLP, ICH, FDA, EMA, and other regulatory requirements.
• Oversee investigations related to OOS, OOT, atypical results, deviations, and laboratory incidents, ensuring timely, scientifically sound resolution and appropriate CAPA recommendations.
• Provide quality oversight for contract partners and contract testing laboratories, including qualification, performance monitoring, audits, quality agreements, and resolution of documentation or compliance issues.
• Maintain and continuously improve systems and processes for CAPA, change control, risk management, compliance, and analytical quality operations.
• Manage audits and inspections related to analytical laboratories and testing activities, including regulatory inspections, customer audits, internal audits, and cGMP compliance audits.
• Review and audit analytical data and CMC sections of NDA and global regulatory filings, as applicable.
• Manage direct reports responsible for Analytical Quality Assurance.

Knowledge, Experience and Skills

• Demonstrated ability to evaluate analytical data, investigations, trends, and product quality risks to make sound, risk-based quality decisions.
• Experience overseeing contract testing laboratories and external partners, including performance monitoring, issue resolution, and quality governance.
• Excellent communication, collaboration, organization, and influencing skills, with the ability to effectively engage senior leadership and cross-functional stakeholders.
• Strong critical thinking, problem-solving, and decision-making skills, with the ability to operate independently in complex and ambiguous environments.
• Proven ability to lead, coach, and develop high-performing teams while fostering a culture of accountability, quality, and continuous improvement.

Qualifications

• Experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or a related GMP-regulated environment, with progressive leadership responsibilities. Bachelor's degree, MS or PhD in chemistry, microbiology, or related scientific field is preferred:
  • 12+ years of relevant experience and a BS or BA
  • 10+ years of relevant experience and a MS
  • 8+ years of relevant experience and a PhD

People Leader Accountabilities

• Create Inclusion -knowingthe business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is:

Bay Area: $210,375.00 - $272,250.00.

Other US Locations: $191,250.00 - $247,500.00.

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.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

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.