Gilead Sciences · 20 hours ago
Sr Director, R&D Quality
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$243K/yr - $315K/yr
8+ years expGilead Sciences is dedicated to creating a healthier world by tackling major diseases and developing life-changing therapies. The Sr Director of R&D Quality will be responsible for designing and implementing quality strategies, leading quality assessments, and ensuring compliance across the Inflammation therapeutic area.
BiotechnologyHealthcarePharmaceuticalManufacturingBiopharmaHealth Care
Responsibilities
Design and implement the Quality Strategy for the Inflammation TA
Lead and direct Quality assessments across the Inflammation portfolio, conducting comprehensive evaluations that identify risks, assess overall quality health, and guide prioritization of mitigation and improvement efforts
Lead the analysis and interpretation of Quality data for the presentation and reporting to functional and executive leadership
Lead and supervise the management of critical and/or complex quality events as well as the assessment of serious breaches, for the Inflammation TA
Ensure the development of robust, comprehensive action plans that proactively address Quality and compliance risks
Lead Quality activities to support product submissions and responses to Health Authorities
Establish strong partnership with key functional leaders, including Clinical Development, Clinical Operations, Regulatory Operations, Safety and Clinical Data Sciences
Generate clear and actionable insights that strengthen the Audit and Inspection Management programs, ensuing oversight activities are focused where they matter most
Drive implementation of Quality by Design principles in Inflammation development programs
Collaborate with Virology and Oncology TA Leads aligning cross TA risks and the staff resourcing strategy
Drive risk-based decision making by delivering clear, insightful rationale that reflect sound judgement and deep Quality expertise
Participate/provide expertise in in licensing and collaboration activities as applicable
Support management of internal inspection preparation activities and overall readiness throughout program life cycle for Gilead study teams
Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations
Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners
Serve as an expert and provide guidance on and interpretation of global GCP regulations and Gilead standards for internal stakeholders
Interface with key external Quality organizations for Gilead development partners and collaborations
Supports overall R&D Quality goals and objectives including but not limited to resource budget and outputs, and line management oversight of the team
Supervise, develop, train and manage internal staff. This includes fostering a commitment to quality in individuals and a culture of quality within the organization
Leads intra or interdepartmental teams such as 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
Must have broad GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required
Track record of experience in managing therapeutic area and/or disease specific 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%
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
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