Gilead Sciences · 10 hours ago
VP, R&D Quality
San Francisco Bay Area
Full-time
Onsite
Director/Executive
15+ years expGilead Sciences is dedicated to creating a healthier world by developing therapies for significant health challenges. The VP of R&D Quality will oversee the global R&D and Medical Affairs quality strategy, ensuring compliance and quality management across all therapeutic areas. This role involves leading a global team and collaborating with stakeholders to maintain regulatory standards and improve processes.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide strategic leadership to the global R&D Quality & Medical Governance organization including, but not limited to, clinical compliance and pharmacovigilance, electronic systems and laboratory compliance, and quality documents and training administration
Provide oversight to Medical Affairs quality and governance and collaborate with Gilead’s Chief Compliance Officer on healthcare compliance execution
Promote a culture of GxP quality across R&D with the highest levels of integrity to meet all global standards
Represent Gilead and the R&D Quality and Medical Governance organization in meetings with regulatory authorities and other stakeholders around the world
Ensure that appropriate quality measures and controls are in place to align with and support the requirements of industry laws, rules, regulations and guidance documents
Enable efficiency and continuous improvement through the build-out of process capabilities, including a Global Process Owner network, process maps and end-to-end visualization of R&D activities
Ensure ongoing compliance in R&D operations and prepare for regulatory agency inspections and internal audits around the world
Oversee the management of all R&D quality issues, including regulatory compliance with CAPAs, transaction monitoring, quality control, continuing education/tracking and data privacy (in collaboration with the Privacy, Cybersecurity and Information Governance team)
With respect to R&D quality, lead risk assessments and implement compliance monitoring and testing program across R&D
Set the strategic direction for the risk management and engagement of R&D quality for third-party vendors
Lead the approach for employee training sessions on internal GxP policies and procedures
Collaborate with key stakeholders for R&D quality audit programs to develop audit strategy in order to identify organizational risks
Provide strategic vision for inspection management and responses, working closely with global regulatory agencies
Responsible for continuous optimization of procedural documents and associated training
Drive R&D Quality management review program to assure visibility and drive continuous improvement
Serve on Enterprise Quality Council, representing R&D, to enable end-to-end GxP oversight and contribute to integrated quality reviews with Gilead executive management including the SVP of Quality Assurance with the manufacturing organization
Qualification
Required
15+ years of comprehensive regulatory compliance leadership experience in the pharmaceutical industry
Bachelor's degree required; advanced degree (Master's or PhD) or healthcare specialty (MD or PharmD) preferred
Proven ability to lead, influence, and demonstrate cross-functional collaboration to ensure R&D quality
Strong understanding of the required elements of a quality program on a global scale, including health authority rules and regulations, industry guidance, and other issues impacting the development of pharmaceutical products
Experience identifying innovative technologies that scale across the enterprise to meet business needs
Demonstrated ability to collaborate with all levels of management; strong influencing skills and business acumen
Proven experience working in a highly matrixed, complex, and fast-paced rapidly changing global environment
Experience driving out inefficiencies at scale
Extensive history working with regulatory health authorities and complying with required regulatory guidelines including inspection readiness and follow-up
Demonstrated ability to build, mentor, and develop a high performing global leadership team
Proven skills at Quality risk-based decision making
Preferred
advanced degree (Master's or PhD) or healthcare specialty (MD or PharmD)
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
2026-01-16
FierceBiotech
2026-01-16
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