Sr Manager, R&D Quality

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

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.

Specific Job 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 Compli