Gilead Sciences · 1 day ago
Sr Director, R&D Quality
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
$243K/yr - $315K/yr
8+ years expGilead Sciences is dedicated to developing therapies that improve lives and tackle major health challenges. They are seeking a Senior Director, R&D Quality to lead and establish strategies for Quality Oversight activities for products in development, ensuring optimized performance and collaboration across various therapeutic areas.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio
Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting
Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership
Lead and oversee lessons learned activities driving continuous improvement
Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities
Oversee and lead critical quality event investigations and serious breach assessments
Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads
Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross therapeutic area risks
Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ
Providing guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management
Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Sciences
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders
Supports overall R&D Quality goals and objectives including but not limited to Quality strategy & goals
Supervise, develop, train and manage internal staff as needed. This includes fostering a commitment to quality in individuals and a culture of quality within the organization
Leads intra or interdepartmental teams such as goal and continuous improvement initiatives
Qualification
Required
Bachelor's degree with 12+ years; Master's degree with 10+ years; or PhD with 8+ years of R&D quality assurance compliance experience
Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required
Proven experience in managing compliance programs required
Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R3) required
Experience leading business process improvement projects required
Proven effective verbal, written, interpersonal skills to include delivering presentations to executives
Recognized as an expert resource on a range of compliance topics
Management of junior and senior staff
Proficient in Microsoft Office suite
Excellent organizational and project management skills
Able to lead and mentor effective cross functional teams
Ability to travel is approximately 20% required
Preferred
Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred
Experience with Inspection and Audit management/CAPA management programs strongly preferred
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
2026-01-08
2026-01-07
2026-01-06
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