Gilead Sciences · 1 day ago
Director, Quality Assurance - Distribution
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$210K/yr - $272K/yr
10+ years expGilead Sciences is committed to creating a healthier world for all people, tackling major health challenges through innovative therapies. The Director of Quality Assurance for Distribution is responsible for ensuring compliance and quality in the distribution of Gilead products across the US market, acting as a liaison with stakeholders to uphold regulatory standards.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Act as Designated Representative (DR), for Gilead Science Inc., responsible for ensuring compliance with National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements as well as all relevant regulations pertaining to current best practice
Responsible for maintaining the California Board of Pharmacy (CA BoP) Wholesale Drug Permit (license) by ensuring all licensee requirements are met
Work with trade operations colleagues to establish and maintain an engagement program for quality with Gilead’s US trading partners/customers
Perform vendor site owner responsibilities in relevant Gilead system relating to Gilead’s US trading partners/customers
Responsible for providing guidance on interpretation and application of existing and new US requirements pertaining to product distribution
Act as the QA SME relating to DSCSA compliance and provide strategic support for operational processes relating to implementation of DSCSA requirements
Act as prescription Drug Marketing Act (PDMA) Quality representative in Gilead’s Sample Compliance Committee (SCC)
Act as Deputy Designated Representative (dDR) for Asegua (a subsidiary of Gilead Sciences Inc), supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice
Lead/Support market actions, including recall, of Gilead products distributed in US market
Support shipping & distribution-related complaints process for US market & investigations into suspect product, as required
Manage QMS records such as deviations (internal & external), CAPAs & Change Controls related to QA Operations supporting US market distribution
Collaborate with Global QA teams as well as working cross-functionally with Trade Operations personnel, Global Supply Chain and other relevant colleagues supporting all aspects of US product distribution
Host NAPB or CA BoP audits of Gilead and interacts closely with external regulators/stakeholders as well as supporting external FDA audits and internal audit programs
Participate in developing/approving Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met
Participate in the development & delivery of training programs relevant to GDP, PDMA & DSCSA compliance as they relate to activities covering US market
Conduct/Participate in gap analyses and risk assessments of processes & procedures against relevant GDP, PDMA & DSCSA guidelines as well as corporate standards
Participate in, or where relevant lead, local and corporate projects, and process improvement initiatives, as required
Qualification
Required
BS/BA degree with 12+ years or MS/MA degree with 10+ years of relevant experience in the pharmaceutical industry with a pharmacy degree or equivalent
Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment
Experience in US market to include supporting/hosting FDA inspections
Demonstrates proficiency in Good Distribution Practices (GDP), Prescription Drug Marketing Act (PDMA), and Drug Supply Chain Security Act (DSCSA) requirements as well as risk management principles
Demonstrates a highly developed knowledge of compliance requirements, and an understanding of current global and regional trends in compliance
Capable of assessing and communicating the impact of relevant requirements to the business
Ability to engage and manage multiple stakeholders to achieve the objective
Demonstrates excellent influencing and negotiation skills
Excellent verbal, written and interpersonal skills are required
Organized with systematic approach to prioritization
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-06
MarketScreener
2026-01-06
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