QA Specialist II

Gilead Sciences • Foster City, CA

1d • $102,085 - $132,110

About The Position

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.

Requirements

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

Responsibilities

• Quality Systems Support 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.
• 3PL & Distribution Oversight 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.
• Procedures, Audits, and Compliance 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.
• Cross‑Functional Collaboration 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level