Sr Manager, Quality Assurance

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
 

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. 

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.  As a Senior Manager, Quality Assurance at Gilead you will provide Quality Assurance leadership and oversight for Gilead’s Global Logistics operations supporting both clinical trial supply and commercial product distribution, with a primary focus on US market drug product supply.

This role is responsible for deviation and CAPA oversight, change management support, quality oversight of third‑party logistics (3PL) service providers, and resolution of all DSCSA‑related events, ensuring full compliance with DSCSA, FDA, and applicable GDP regulations. The role partners closely with Global Logistics, Trade Operations, Supply Planning, and external service providers to ensure compliant, reliable distribution of Gilead products to patients.

The successful candidate will join the Global Product Distribution & Affiliates QA team and be based in La Verne, CA

Quality Systems Oversight 

• Support and/or approve deviations, investigations, and CAPAs associated with Global Logistics clinical and commercial operations, ensuring timely, thorough, and compliant resolution.

• Provide QA oversight and support for change management activities, including changes to distribution processes, transportation lanes, systems, and 3PL operations.

• Review and assess logistics‑related quality records, including shipping documentation, temperature excursions, and environmental monitoring data.

3PL & Distribution Oversight 

• Provide Quality Assurance oversight of primary US market drug product supply 3PL service providers, ensuring adherence to GDP, DSCSA, and Gilead quality standards.

• Monitor quality performance, trends, and metrics across logistics operations and partner with stakeholders to drive continuous improvement.

• Support vendor qualification, ongoing oversight, and issue resolution related to logistics service providers.

DSCSA & Regulatory Compliance 

• Serve as QA lead supporting resolution of DSCSA‑related events, including suspect, illegitimate, and notification events, ensuring compliance with all relevant DSCSA and FDA requirements.

• Partner with Trade Operations, Global Logistics, and external partners to support DSCSA compliance across US distribution activities.

• Support and participate in FDA, NABP, and other regulatory inspections, audits, and internal audit programs related to distribution and logistics.

Procedures, Training & Continuous Improvement 

• Contribute to the development, review, and maintenance of SOPs and quality documentation supporting Global Logistics operations.

• Support development and delivery of training programs related to GDP, DSCSA, and logistics quality requirements.

• Participate in or lead cross‑functional projects and continuous improvement initiatives within GPD&A and Global Logistics.

Requirements

• Bachelors degree and 8+ years of relevant experience OR

• Masters degree and 6+ years of relevant experience OR

• PhD and 2+ years of relevant experience

People Leader Accountabilities

• Create Inclusion - knowing the 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 employees are receiving the feedback and insight needed to grow, develop and realize their purpose. 

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. 

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.

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 [email protected] 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.

Please apply via the Internal Career Opportunities portal in Workday.