Sr Manager, R&D Quality

Gilead Sciences • Foster City, CA

7d

About The Position

This role serves as a strategic partner within Gilead Research and Development (R&D), providing expert guidance on GxP electronic systems compliance and driving digital innovation. The position is responsible for interpreting and applying global regulations related to electronic records, electronic signatures, and data integrity, while collaborating across R&D functional areas and vendor partners to implement robust governance strategies for Electronic Systems Compliance (ESC). Additionally, the role facilitates the adoption and integration of emerging technologies—including Artificial Intelligence (AI), Machine Learning (ML), Robotic Process Automation (RPA), and other digital tools—ensuring compliance, operational efficiency, and continuous improvement. Acting as a subject matter expert, this role promotes best practices, fosters cross-functional alignment, and supports change management to enable a compliant and future-ready digital ecosystem.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees