Gilead Sciences · 19 hours ago
Sr Manager, R&D Quality
San Francisco Bay Area
Full-time
Onsite
Senior Level
$158K/yr - $204K/yr
6+ years expGilead Sciences is dedicated to creating a healthier world by tackling major health challenges through innovative therapies. The Sr Manager, R&D Quality role serves as a strategic partner in ensuring compliance with electronic systems in Gilead's research and development, while driving the adoption of emerging technologies to enhance operational efficiency and data integrity.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provides Electronic Systems Compliance (ESC) oversight for GxP systems utilized in various Gilead Research and Development (R&D) functional areas and/or for vendor partners
Provides input into the development of scope, actions, timelines on CSV projects and manages quality resources for the implementation and validation of computerized systems, including the review and approval of validation deliverables
Provides training on CSV and ESC-related topics to colleagues
Act as a QA lead on change control teams to support GxP systems change control, and for deviations and corrective and preventative actions (CAPAs)
Support periodic reviews and system audit trail reviews of validated systems as QA lead and when needed support de-commissioning of validated systems
Provides guidance to colleagues and vendors on GxP Electronic Systems, including guidance and interpretation on regulations pertaining to electronic records, electronic signatures, and data integrity
Review and interpret global GxP regulations (FDA 21 CFR Part 11, EU Annex 11, ICH guidelines) related to electronic records, electronic signatures, and data integrity
Translate regulatory requirements into practical guidance for system design, validation, and operation
Ensure internal policies and vendor practices align with applicable regulations
Investigate and resolve data integrity issues, including root cause analysis and corrective actions
Collaborate with Gilead Research and Development (R&D) functional areas to facilitate the utilization and applicability of emerging technologies, including Artificial Intelligence (AI), Machine Learning (ML), Robotic Process Automation (RPA), and other digital tools
Evaluate emerging technologies (AI, ML, RPA, digital tools) for applicability within Gilead’s R&D processes
Conduct feasibility studies and proof-of-concept (POC) projects to validate technology benefits
Recommend technology adoption strategies based on regulatory compliance, scalability, and business impact
Ensure emerging technologies comply with GxP, data integrity, and regulatory standards
Identify opportunities for process optimization and efficiency gains through digital tools
Collaborate in the formulation and implementation of the comprehensive governance strategy for Electronic Systems Compliance (ESC) and socialize with various Gilead Research and Development (R&D) functional areas and/or vendor partners
Participate in defining the overall governance framework for Electronic Systems Compliance (ESC), ensuring alignment with Gilead’s R&D objectives and regulatory requirements
Contribute to drafting policies, standards, and procedures that govern electronic systems across the organization
Identify key compliance risks and propose mitigation strategies within the governance model
Support the rollout of governance processes across R&D functional areas and vendor partners
Engage with R&D stakeholders (Clinical, Regulatory, Quality, Data Management, etc.) to align governance practices with operational needs
Facilitate workshops and working sessions to gather input and drive consensus on governance requirements
Act as a liaison between ESC governance teams and functional areas to resolve conflicts and clarify expectations
Qualification
Required
Doctorate and 2+ years of relevant experience OR
Master's and 6+ years of relevant experience OR
Bachelor's and 8+ years of relevant experience OR
Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment
Preferred
Demonstrated ability to be a fast learner
BA/BS or advanced degree in computer science, information systems, life sciences or related field with technology, quality or compliance experience in the biopharma or related industry
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
Knowledge of software development lifecycle (SDLC) methodologies and current practices and tools
Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of systems and applications QA, GCP, GCLP and GVP, as evidenced by ability to independently identify potential quality and compliance issues and recommend appropriate remediations
Strong analytical thinking skills and attention-to-detail, as evidenced by the ability to effectively assess complex systems and data and accurately determine the quality and compliance implications
Strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through abilities to assume assignments and projects with increasing independence
Ability to lead and influence programs, projects and/or initiatives
Strong interpersonal skills and understanding of team dynamics
Proven ability to work successfully in a team-oriented, highly matrixed environment
When needed, ability to travel
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
2026-01-20
2026-01-16
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