Sr Manager, R&D Quality

Role Summary

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 interprets and applies global regulations related to electronic records, electronic signatures, and data integrity, collaborating across R&D functional areas and vendor partners to implement governance strategies for Electronic Systems Compliance (ESC). It also facilitates the adoption and integration of emerging technologies—including AI, ML, and RPA—while ensuring compliance, efficiency, and continuous improvement.

Responsibilities

• Provides ESC oversight for GxP systems utilized in various R&D functional areas and/or for vendor partners.
• Provides input into scope, actions, timelines on CSV projects and manages quality resources for the implementation and validation of computerized systems, including review and approval of validation deliverables.
• Provides training on CSV and ESC-related topics to colleagues.
• Acts as a QA lead on change control teams to support GxP systems change control, and for deviations and CAPAs.
• Supports periodic reviews and system audit trail reviews of validated systems as QA lead and, when needed, supports 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 R&D functional areas to facilitate the utilization and applicability of emerging technologies, including AI, ML, RPA, and other digital tools.
• Evaluate emerging technologies for applicability within R&D processes; conduct feasibility studies and POC projects to validate benefits; recommend adoption strategies based on regulatory compliance, scalability, and 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 formulation and implementation of the governance strategy for ESC and socialize with R&D functional areas and vendor partners.
• Participate in defining the governance framework for ESC; contribute to drafting policies, standards, and procedures; identify key compliance risks and propose mitigation strategies.
• Support rollout of governance processes across R&D functional areas and vendor partners; engage with stakeholders to align governance 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.

Qualifications

• Required: Doctorate and 2+ years of relevant experience
• Required: Master’s and 6+ years of relevant experience
• Required: Bachelor’s and 8+ years of relevant experience
• Required: Relevant work experience consists of working in a pharmaceutical quality control, quality assurance or compliance environment
• Preferred: Demonstrated ability to be a fast learner
• Preferred: BA/BS or advanced degree in computer science, information systems, life sciences or related field with technology, quality or compliance experience in biopharma or related industry
• Preferred: Demonstrated ability to be flexible and adaptable to change; move between projects easily; provide support/expertise where needed
• Preferred: Knowledge of SDLC methodologies and current practices and tools
• Preferred: Knowledge of the drug development process and understanding of QA, GCP, GCLP and GVP; ability to identify quality/compliance issues and recommend remediations
• Preferred: Strong analytical thinking and attention to detail; ability to assess complex systems and data for quality and compliance implications
• Preferred: Strong communication and writing skills; project management skills; proficiency with Microsoft Office; ability to take on assignments with increasing independence
• Preferred: Ability to lead and influence programs, projects and initiatives
• Preferred: Strong interpersonal skills and teamwork
• Preferred: Proven ability to work successfully in a highly matrixed environment
• Preferred: When needed, ability to travel

Education

• Doctorate; or Master’s; or Bachelor’s with extensive relevant experience as described above

Additional Requirements

• When needed, ability to travel