VP, R&D Quality

Role Summary

VP, R&D Quality will own the vision, recommendations, and execution of the worldwide R&D and Medical Affairs quality strategy as an independent function for all investigational and marketed products across Gilead’s therapeutic areas. The role leads a global team, provides quality management oversight across regions (including Medical Affairs), and partners with stakeholders to ensure alignment with evolving regulations and global standards.

• Provide strategic leadership to the global R&D Quality & Medical Governance organization, including clinical compliance, pharmacovigilance, electronic systems, laboratory compliance, and training administration.
• Oversee Medical Affairs quality and governance and collaborate with the Chief Compliance Officer on healthcare compliance execution.
• Promote a culture of GxP quality across R&D with integrity to meet global standards.
• Represent Gilead in meetings with regulatory authorities and other stakeholders worldwide.
• Ensure quality measures and controls align with industry laws, regulations, and guidance documents.
• Drive process capability improvements, including Global Process Owner networks, process maps, and end-to-end visualization of R&D activities.
• Ensure ongoing compliance in R&D operations and prepare for inspections and internal audits globally.
• Oversee management of R&D quality issues, including CAPAs, transaction monitoring, quality control, continuing education/tracking, and data privacy in collaboration with the Privacy, Cybersecurity and Information Governance team.
• Lead risk assessments and implement compliance monitoring and testing programs across R&D.
• Set strategic direction for risk management and engagement of R&D quality with third-party vendors.
• Lead employee training sessions on internal GxP policies and procedures.
• Collaborate on R&D quality audit programs to identify organizational risks.
• Provide strategic vision for inspection management and responses with global regulatory agencies.
• Continuously optimize procedural documents and related training.
• Drive the R&D Quality management review program for visibility and continuous improvement.
• Serve on the Enterprise Quality Council representing R&D to enable end-to-end GxP oversight and contribute to integrated quality reviews with Gilead executive management.

• 15+ years of comprehensive regulatory compliance leadership experience in the pharmaceutical industry.
• Bachelor’s degree required; advanced degree (Master’s or PhD) or healthcare specialty (MD or Pharm
  
  D) preferred.
• Proven ability to lead, influence, and collaborate cross-functionally to ensure R&D quality.
• Strong understanding of global quality program elements, including health authority rules, regulations, and industry guidance.
• Experience identifying innovative technologies that scale across the enterprise to meet business needs.
• Demonstrated ability to collaborate with all levels of management; strong influencing skills and business acumen.
• Experience in a highly matrixed, complex, fast-paced global environment.
• Experience driving operational efficiencies at scale.
• Extensive history working with regulatory health authorities, including inspection readiness and follow-up.
• Ability to build, mentor, and develop a high-performing global leadership team.
• Proven skills in quality risk-based decision making.

• Strong leadership and people-management capabilities.
• Strategic thinking with ability to translate regulatory requirements into practical processes.
• Excellent communication and negotiation skills with internal and external stakeholders.
• Risk management, auditing, and inspection readiness expertise.
• Ability to drive cross-functional collaboration in a dynamic, global environment.