About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. Our revolutionary therapies, such as cures for hepatitis C and transformative HIV treatments, have improved millions of lives globally. We are at the forefront of advancements in oncology and inflammatory diseases, driven by a mission to confront public health challenges and ensure access to innovative medicines. Headquartered in Foster City, California, Gilead fosters a collaborative environment where bold ambitions meet scientific innovation.

Role Overview

The Director, Quality Assurance - Distribution, plays a pivotal role in Gilead's Global Product Distribution & Affiliates (GPD&A) group. Based in Foster City, California, this position oversees quality assurance for Gilead products distributed across the US market. As the Designated Representative (DR) for Gilead Sciences Inc., you will ensure unwavering compliance with Good Distribution Practices (GDP), National Association of Boards of Pharmacy (NABP) Verified-Accredited Wholesale Distributors (VAWD) standards, and California Board of Pharmacy (CA BoP) requirements. This leadership role demands expertise in Drug Supply Chain Security Act (DSCSA), Prescription Drug Marketing Act (PDMA), and robust quality management systems to safeguard product integrity from manufacturer to patient.

Strategic Impact

In this role, you will act as the QA subject matter expert (SME), guiding internal teams and external partners through evolving regulations. Your work directly supports Gilead's commitment to delivering safe, effective therapies for HIV, oncology, and inflammatory conditions, ensuring every product reaches patients without compromise.

Key Responsibilities

Lead quality assurance efforts for US product distribution with responsibilities including:

• Acting as Designated Representative (DR) for Gilead Sciences Inc., maintaining VAWD accreditation and CA BoP Wholesale Drug Permit compliance.
• Establishing quality engagement programs with US trading partners and performing vendor site owner duties in Gilead systems.
• Providing strategic guidance on DSCSA implementation, PDMA compliance, and GDP best practices.
• Managing market actions like recalls, shipping complaints, suspect product investigations, deviations, CAPAs, and change controls.
• Hosting NABP, CA BoP, and FDA audits while collaborating with Global QA, Supply Chain, and Trade Operations.
• Developing SOPs, training programs, conducting gap analyses, risk assessments, and leading process improvement projects.

Qualifications & Requirements

To excel as Director, Quality Assurance - Distribution, candidates need:

• BS/BA degree with 12+ years or MS/MA degree with 10+ years of relevant pharmaceutical industry experience; pharmacy degree strongly preferred.
• Proven track record as Designated Representative or in wholesale distribution quality assurance.
• In-depth knowledge of US regulations including DSCSA, PDMA, GDP, VAWD, and state pharmacy laws.
• Strong leadership skills with experience in audits, vendor management, QMS, and cross-functional collaboration.
• Excellent communication abilities to interact with regulators, stakeholders, and internal teams.

Behaviors & Experience

Successful candidates demonstrate determination, strategic thinking, and a passion for quality in life-changing therapies. Experience supporting subsidiaries like Asegua and participating in Sample Compliance Committees is advantageous.

Benefits & Perks

Gilead Sciences offers a premium compensation package tailored to attract top talent:

• Competitive base salary estimated at $250,000 - $320,000 annually, plus bonuses and equity.
• Comprehensive health benefits including medical, dental, vision, and wellness programs.
• Generous 401(k) matching, tuition reimbursement, and paid parental leave.
• Flexible work options, onsite fitness centers, and employee stock purchase plans.
• Access to cutting-edge facilities in Foster City, promoting work-life balance and innovation.

Career Growth

At Gilead, people leaders are central to our culture of inclusion and empowerment. This Director role offers pathways to executive QA leadership, global supply chain positions, or broader regulatory affairs. Benefit from mentorship, leadership development programs, and opportunities to shape Gilead's future in HIV, oncology, and inflammatory diseases. Our commitment to employee aspirations ensures continuous growth in a dynamic biopharma environment.

Why Join Gilead

Join a team united in bold ambitions against devastating diseases. Gilead's work in HIV prevention, oncology breakthroughs, and inflammatory therapies positions you at the heart of scientific progress. In Foster City, collaborate with passionate experts, leverage state-of-the-art resources, and make a tangible impact on global health. We prioritize diversity, equity, and inclusion, creating an environment where every voice drives innovation.

Role FAQs

Q: What is the primary focus of this role?
A: Ensuring GDP compliance and acting as DR for US distribution of Gilead products.

Q: Is relocation support available?
A: Gilead offers competitive relocation packages for qualifying candidates.

Q: What experience level is required?
A: 10-12+ years in pharma QA, preferably with pharmacy background and regulatory expertise.

Q: How does this role support Gilead's mission?
A: By safeguarding product quality, enabling safe delivery of therapies for HIV, cancer, and more.

Q: What are the next steps to apply?
A: Submit your resume via Gilead's career portal and connect with our talent acquisition team.