Gilead Sciences · 1 day ago
Senior Director, Quality Assurance - Distribution
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$243K/yr - $315K/yr
14+ years expGilead Sciences is dedicated to creating a healthier world for all people, tackling diseases and developing life-changing therapies. The Senior Director, Quality Assurance - Distribution will oversee QA operations across the US, Canada, and LATAM markets, ensuring compliance and developing strategies to enhance quality assurance processes within the distribution network.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Serve as a key member of the GPD&A Leadership Team, who are collectively responsible for implementation of cohesive & effective QA processes across the Gilead distribution network as well as developing medium- and long-term strategic plans for all regions, which supports the overall strategic plans for the quality organization
Coach and mentor direct reports to drive independence, development, and performance & provide leadership to ensure a safe, respectful, and inclusive work environment
Manage financial budget, resource and workload balance with team to ensure local QA activities are performed to meet timelines and quality & compliance expectations in an equitable manner as well as ensuring that key performance indicators are monitored and reported, and key project timelines & milestones are tracked. Provides guidance on prioritization when necessary
Act as Senior QA advisor to in-country & cluster (group of countries) QA leads with interpreting the local & regional regulatory requirements as they pertain to the distribution of Gilead products
Act as senior liaison with Gilead’s distribution partners (in US, Canada & LATAM markets) related to escalations & critical/major issues, as well as with changes that impact Gilead’s business models with these partners
Interfaces with regulatory agencies as required, representing Gilead to authorities and regulatory inspectorate bodies
Provide leadership for local market activities across US, Canada & LATAM regions supporting product recall and support periodic product recall challenges to ensure Gilead’s in-country distribution operations are in a state of continuous readiness in the event of needing to support product recall or other types of market action
Lead highly complex investigations, including development and implementation of corrective and preventative action (CAPA), as required
Partner with QA colleagues to develop strategies supporting Gilead’s in-country QA operations, including introduction of standards, processes & procedures supporting these strategies
Collaborate cross-functionally and geographically with key stakeholders to establish strong working relationships with quality groups, colleagues in Regulatory Affairs, Global Trade Ops, Global Commercial Operations & Legal functions as well as other Gilead global functions and external distribution partners
Act as an internal escalation contact supporting complex and high impact quality issues, concerns, and decisions
Prime QA representative on cross-functional regional/global projects & process improvement initiatives of considerable impact to the business
Act as deputy for the Executive Director, as required, supporting complex and high impact quality-related issues, escalations & other topics
Qualification
Required
14+ years of relevant experience and a bachelor's degree in science or related fields, or 12+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA. Alternatively, 20+years relevant experience in pharmaceutical warehouse & distribution required
Comprehensive knowledge and experience in quality assurance in highly regulated distribution environments
Prior people management experience required
Broad experience across areas like customer service, warehouse operations, logistics & transport required and understanding of Oral Solid Dosage, Parenteral and Aseptic operations is beneficial
Demonstrates in-depth understanding and application of GDP principles, concepts, and standards in US, Canada & LATAM as well as having an appreciation of them in other regions across the globe
Capable of developing complex concepts, techniques, and standards and new applications based on quality principles and theories
Anticipates shifts in industry trends and regulatory environment that will impact Gilead's business needs and positions the function to respond accordingly
Demonstrates strong knowledge of aseptic processing, solid dose and general pharmaceutical manufacturing
Capable of developing solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist
Demonstrates extensive knowledge of industry best practices and trends
Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills
Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums
Demonstrates the ability to identify, understand and exceed customer expectations
Demonstrates experience and ability to manage staff
Demonstrates the ability to initiate and support change and respond to change requirements by continually striving to improve process or business areas, consistent with organizational strategy
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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