Sr Manager, R&D Quality

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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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 technologiesincluding Artificial Intelligence (AI) Machine Learning (ML) Robotic Process Automation (RPA) and other digital toolsensuring 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 Gileads 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 Gileads 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.

Basic Qualifications:

• Doctorate and 2 years of relevant experience OR
• Masters and 6 years of relevant experience OR
• Bachelors and 8 years of relevant experience OR
• Relevant work experience consists of working in a pharmaceutical quality control quality assurance or compliance environment.

Preferred Qualifications:

• 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.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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