QA Specialist II

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.

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 QA Specialist II at Gilead you will provide support for Gilead’s Global Logistics operations across both clinical and commercial supply chains.

This role is responsible for deviation and CAPA review, change management support, and quality oversight of third‑party logistics (3PL) service providers. The Specialist ensures compliance with global Good Distribution Practice (GDP) requirements and supports consistent, high‑quality product distribution to global markets.

This role is based in Foster City, reporting to the Senior Director, Quality Assurance – Global Product Distribution & Affiliates.

• Review and approve deviations, investigations, and CAPA records associated with Global Logistics activities.
• Support change controls related to distribution processes, transportation lanes, and 3PL operational activities.
• Conduct quality reviews of distribution and operational documentation (e.g., shipping records, environmental monitoring, temperature excursions).
• Partner with QA colleagues to ensure compliance with GDP, GMP, and applicable regulatory requirements.

• Provide QA oversight of global 3PL partners, including assessment of operational compliance, quality performance, and adherence to Gilead standards.
• Monitor and review logistics data to identify quality trends or potential process improvements.
• Contribute to routine quality metrics reporting and partner with Logistics to address identified gaps.

• Participate in development, revision, and maintenance of Standard Operating Procedures (SOPs) related to distribution and logistics operations.
• Support internal audits and external inspections pertaining to distribution activities.
• Ensure consistent application of quality policies, procedures, and industry best practices across the logistics network.

• Collaborate closely with Global Logistics, Supply Chain, Warehouse Operations, Customer Service, Regulatory, and other cross‑functional groups to ensure compliant product distribution.
• Provide QA input into operational improvements, issue resolution, and process standardization.

• Bachelors degree and 4+ years of relevant experience OR
• Masters degree and 2+ years of relevant experience

The salary range for this position is: $ - $. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This…