About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company dedicated to creating a healthier world for all people. For over 35 years, Gilead has pioneered breakthroughs in treating some of the world's most challenging diseases, including HIV, viral hepatitis, COVID-19, and cancer. The company's innovative therapies have delivered a cure for hepatitis C, revolutionary advancements in HIV treatment and prevention, and significant progress in oncology and inflammatory diseases. Headquartered in the United States, Gilead operates globally, collaborating with partners to ensure access to life-changing medicines. With a relentless commitment to scientific innovation, quality, and compliance, Gilead fosters a culture where every employee contributes to bold ambitions that improve patient lives worldwide.

Role Overview

The Director, GVP Audits position at Gilead Sciences, based in Parsippany, New Jersey (with options in Stockley Park or Cambridge, UK), is a pivotal leadership role within the R&D Quality Organization. This position drives audit excellence and ensures global compliance across pharmacovigilance (GVP) activities. Reporting to the Head of GVP Audits, the Director oversees complex audits involving R&D functions, external vendors, and critical pharmacovigilance workstreams. Ideal candidates are local to Parsippany and bring strong collaboration skills to work with cross-functional stakeholders like R&D Quality Business Partners, Patient Safety, and the Qualified Person for Pharmacovigilance (QPPV). This role emphasizes proactive risk identification, mitigation, and the strategic management of the GVP Audit Master Index, annual plans, and long-range audit strategies.

Key Responsibilities

In this role, you will lead the GVP Audit Program with accountability for a broad spectrum of activities across affiliates, partners, vendors, and internal PV processes. Key responsibilities include:

• Driving the strategic execution and enhancement of the GVP Risk-Based Audit Approach, including long-range and annual plans, while serving as Process Owner for related documentation and risk assessments.
• Leading internal R&D Quality audits for assigned groups or locations, executing annual audit plans with rigor, and delivering high-quality audit reports.
• Ensuring timely CAPA closure, effectiveness checks, and continuous improvement in audit processes, systems, and standards.
• Acting as a trusted advisor to senior stakeholders on GVP compliance, regulatory requirements, and Gilead policies.
• Supporting regulatory inspections, inspection readiness, and partnering with R&D Quality Extended Leadership to build quality capabilities and foster compliance culture.

GVP Audit Operations Excellence

You will serve as the primary point-of-contact for assigned R&D groups, providing expert guidance on GVP regulations. Collaborate with Inspection Management, Quality Business Partners, and SMEs to prepare partner audits, conduct risk assessments, and maintain inspection readiness for GVP programs.

Qualifications & Requirements

To succeed as Director, GVP Audits, candidates need extensive experience in pharmacovigilance auditing within biopharmaceutical R&D. Essential qualifications include:

• Deep expertise in GVP regulations, global compliance standards, and risk-based auditing methodologies.
• Proven leadership in managing complex audit programs, including vendor and affiliate audits.
• Strong skills in CAPA management, stakeholder collaboration, and process optimization.
• Experience supporting regulatory inspections and driving continuous improvement initiatives.
• Excellent communication and strategic thinking to influence senior leaders and embed a quality mindset across R&D.

Preference for candidates local to Parsippany, NJ, with the ability to travel as needed for global audits.

Benefits & Perks

Gilead Sciences offers a comprehensive benefits package designed to support your well-being and professional success:

• Competitive salary estimated at $230,000 - $280,000 USD annually, based on biopharmaceutical sector rates in New Jersey with a buffer for top talent.
• Robust health insurance, including medical, dental, and vision coverage.
• 401(k) retirement savings with company match and employee stock purchase plans.
• Generous paid time off, parental leave, and flexible work options.
• Professional development programs, tuition reimbursement, and leadership training.

Career Growth

At Gilead, career advancement is a priority. As a People Leader, you will drive cultural evolution, employee inclusion, and empowerment. This Director role positions you for growth within R&D Quality leadership, potentially advancing to Head of Audits or broader Quality executive positions. Gilead invests in your development through mentorship, cross-functional projects, and exposure to global health challenges in HIV, oncology, and inflammatory diseases.

Why Join Gilead

Joining Gilead means contributing to transformative therapies that address HIV, oncology, and inflammatory diseases, backed by uncompromising quality and compliance. Work in a collaborative environment where your expertise in GVP audits directly impacts patient safety and innovation. Parsippany's strategic location offers proximity to key biopharma hubs, enhancing networking and career opportunities. Be part of a team united in confronting public health challenges and creating possible together.

Role FAQs

Q: Is this role hybrid or on-site? Ideally on-site in Parsippany, NJ, with strong collaboration needs; local candidates preferred.

Q: What is the reporting structure? Reports to the Head of GVP Audits within R&D Quality.

Q: Does it involve international travel? Yes, for global audits and stakeholder engagements.

Q: What experience level is required? Senior-level expertise in GVP audits and pharmacovigilance compliance.

Q: How does this role support Gilead's mission? By ensuring audit excellence and compliance, enabling safe delivery of therapies for HIV, cancer, and more.