Gilead Sciences · 17 hours ago
Manager, Quality Assurance - Distribution
San Francisco Bay Area
Full-time
Onsite
Senior Level
$136K/yr - $176K/yr
6+ years expGilead Sciences is dedicated to creating a healthier world and is seeking a Manager of Quality Assurance for their Global Product Distribution & Affiliates group. This role is responsible for ensuring compliance with quality requirements and Good Distribution Practices for Gilead products distributed within the US market.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Act as Designated Representative (DR), for Asegua, 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 Californian Board of Pharmacy Wholesale Drug Permit (license) by ensuring all licensee requirements are met
Manage medical samples process for Gilead products in the US market and ensure compliance with the Prescription Drug Marketing Act (PDMA)
Support the engagement program for quality with Gilead’s US trading partners/customers
Support operational activities relating to implementation of the Drug Supply Chain Security Act (DSCSA) requirements, as required
Act as Deputy Designated Representative (dDR) for Gilead Sciences Inc., supporting the DR to ensure compliance with state pharmacy state and federal laws and regulations pertaining to current best practice
Support market actions, including recall, of Gilead/Asegua products distributed in US market
Support Complaints process for US market and investigations into suspect product, as required
Generate, review and/or approve QMS records such as deviations (internal & external), CAPAs & Change Controls related to QA Operations supporting US market
Support implementation of existing and new US requirements & guidelines pertaining to product distribution in Gilead’s processes & procedures
Collaborate with Global QA teams as well as working cross-functionally with Trade Operations personnel and other relevant colleagues supporting all aspects of US product distribution
Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required
Generate & maintain Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met
Deliver training to colleagues in processes & procedures relevant to GDP compliance as it relates to activities covering US market
Participate in gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards
Participate in local and corporate projects and process improvement initiatives, as required
Qualification
Required
6+ years of relevant experience in the pharmaceutical industry and a BS or BA (a pharmacy degree or equivalent an advantage) or 4+ years of relevant experience and a MS or MA
Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment
Experience in US market to include supporting FDA inspections
Demonstrates proficiency in Good Distribution Practices (GDP), and Drug Supply Chain Security Act (DSCSA) and Prescription Drug Marketing Act (PDMA) requirements
Capable of assessing and communicating the impact of relevant requirements to the business and ability to engage with multiple stakeholders to achieve shared objectives
Excellent organization and prioritization skills and ability to work on specified projects with tight timelines is required
Demonstrates excellent attention to detail, and ability to consistently meet high standards required in Compliance
Demonstrates excellent verbal, written, and interpersonal communication skills
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
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
2026-01-09
2026-01-08
2026-01-07
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