Assoc Director, R&D Quality

The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as a key role within Gilead’s R&D Quality Organization. This role is responsible for executing internal GVP audits, supporting E-System/Digital audits, as well as, support or lead complex audits across the broader R&D, vendor, and pharmacovigilance work streams.

This position requires close collaboration with cross‑functional stakeholders, including R&D Quality Business Partners (QBPs), Inspection Management, Patient Safety, and other relevant departments. In partnership with GCP and E-System Audit groups, this role helps shape, communicate, and implement the R&D Quality Annual Audit Program.

Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development and operational execution of the GVP audit function. Responsibilities include developing and improving audit tools and procedures, ensuring the effectiveness of corrective and preventive actions (CAPAs), and providing updates through quality forums and internal communications regarding audit outcomes and CAPAs.

Beyond auditing, this role supports regulatory inspections, readiness, and partners with the R&D Quality Extended Leadership team with responsibilities for helping build and shape quality capabilities, enhance process improvements and transparency. This is a quality assurance role, helping maintain global compliance, reinforcing audit excellence, and ensuring the consistent delivery of high‑quality audits, supporting Gilead’s mission to advance transformative therapies.

Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life‑saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life‑saving therapies to patients around the world?

• Accountable for the successful oversight and completion of a broad spectrum of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes.
• Lead internal R&D quality audits for assigned R&D groups or locations.
• Provide subject matter expertise and support to project teams.
• Develop, drive, or support continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to the overall quality mindset and culture.

• Act as a primary point‑of‑contact to assigned R&D groups and advise on: GVP regulatory requirements, changing legislation, and relevant Gilead policies and procedures supporting audits and pharmacovigilance activities.
• Execute on the strategic audit plan. Plan, schedule, and conduct GVP audits in accordance with the audit plan.
• Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.
• Collaborate with R&D Quality Business Partners and stakeholder SMEs.
• Support risk assessment activities, in partnership with risk program and SMEs.
• Support the overall inspection readiness of the GVP Audit program, including preparation for and participation in inspections.
• Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
• Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
• Support the E‑Systems/Digital Audit program, as needed, ensure adherence to regulations and industry best practices, and maintain an external network to assure current understanding of industry…