Director, GVP Audits in Cambridge

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.

As a Director, GVP Audits, at Gilead you will:

• Play a leadership role within Gilead’s R&D Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities.
• Be responsible for the strategic execution of internal GVP audits and support the E-System/Digital audit program.
• Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance workstreams and processes.

This position requires strong collaboration with cross-functional stakeholders, including R&D Quality Business Partners (QBPs), Patient Safety, and QPPV. The Director will work with stakeholders to proactively identify, evaluate, and mitigate pharmacovigilance compliance risks. In addition, the Director will be responsible for the GVP Audit Master Index and the strategic and operational activities of the GVP Risk-based Audit process (Annual and Long Range Plans). Reporting to the Head of GVP Audits, the Director contributes to the vision, strategy, and operational delivery of the GVP Audits function.

Responsibilities include developing robust audit tools and procedures, optimizing resource planning, ensuring corrective and preventive actions (CAPAs) effectiveness, and providing transparent updates through quality governance forums. Beyond auditing, this role supports regulatory inspections and R&D inspection readiness, and partners with the R&D Quality Extended Leadership team to build quality capabilities, drive process improvements and foster a culture of compliance and continuous improvement.

The Director ensures audit excellence and consistency, reinforcing Gilead’s mission to advance transformative therapies, with uncompromising quality and compliance.

Responsibilities

• 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.
• Responsible for driving the strategic execution and ongoing enhancement of the GVP Risk-Based Audit Approach, encompassing long-range and annual plans.
• Serve as Process Owner for all related documentation, strategy materials, and risk assessments.
• Lead internal R&D Quality audits for assigned R&D groups or locations.
• Drive continuous improvement initiatives to enhance audit processes, systems, and standards, embedding a strong quality mindset across R&D.
• Serve as a trusted advisor to senior stakeholders on GVP compliance and audit strategy.

GVP Audit Operations

• Act as a primary point-of-contact to assigned R&D groups and provide expert guidance on GVP regulatory requirements; relevant Gilead policies and procedures.
• Execute the annual audit plan: Plan, schedule, and conduct GVP audits with rigor and consistency.
• Deliver high quality audit reports and ensure timely CAPA closure and effectiveness checks.
• Collaborate with R&D Inspection Management (IM), Quality Business Partners (QBPs) and stakeholder SMEs to prepare PV partner audits from external PVA partners.
• Lead and support risk assessment activities, in partnership with risk management teams.
• Support the overall inspection readiness of the GVP Audit programs, and actively participate in regulatory inspections as required.
• Oversee contractor auditors, ensuring quality and timely delivery of assigned audits and quality tasks.
• Support the E-Systems/Digital Audit program as needed, ensure adherence to regulations and industry best practices.
• Maintain an external network to assure current understanding of industry trends.

Quality Management

• Evaluate systems, processes, documentation to ensure ongoing compliance and continuous improvement.
• Partner with the Audit Team leadership to implement an Effectiveness Check strategy, in partnership with GCP/GLP and E-system Audit Heads for Audit related CAPAs.
• Stay current with evolving global PV regulations and guidance, translating requirements into actionable strategies.
• Provide insights and updates for quality forums and management reviews.

Training & Development

• Develop and deliver GVP audit training for assigned R&D quality groups.
• Develop and deliver targeted GVP audit and audit skill training, ensuring GVP Audits team is equipped with the knowledge and skills to maintain compliance and audit excellence.
• Build strong relationships with key stakeholders, including contract auditors, functional leaders and teams to foster collaboration and knowledge sharing.

Education & Experience

• BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including significant relevant experience working in quality, compliance, pharmacovigilance, or a related field.
• Extensive experience leading GVP audits, in the biopharma or related industry.

Knowledge & Other Requirements

• Proficiency in pharmacovigilance regulatory requirements (Global) is a must.
• Expert-level experience working with GVP processes and systems is required.
• Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits.
• Broad experience participating in cross-functional projects and teams with responsibilities related to pharmacovigilance and quality system activities.
• Significant experience leading quality, compliance or related projects in the biopharma or related industry, including leading continuous improvements such as new or updated business processes, systems and/or SOPs.
• Experience working with total quality management methodologies, such as Lean Six Sigma, is preferred.
• Certification as a Quality Auditor is preferred.
• Expert knowledge of the drug development process and GVP, including global regulations (FDA, EMA, ICH) and their application to cross-functional drug development.
• Thorough knowledge of standards, systems, policies, and procedures that enable QMS operations and compliance within the biopharma industry, specifically those related to GVP.
• Proven effectiveness in making appropriate decisions independently for relatively complex projects or related issues, as evidenced by past decision-making track record.
• Proven abilities to assume increasing scope and complexity, as evidenced by past successes with team and project leadership, strategic cross-functional partnering, and key contributions to strategy, operational and infrastructure development.
• Advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex information and understanding the quality and compliance implications on the portfolio.
• Track record of successful interaction and collaboration with other functions and with senior leadership, on key projects and deliveries supporting quality and compliance.
• Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
• Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
• Proven abilities to anticipate problems of varying complexity and lead the resolution of these in a collaborative manner, across functions.
• Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
• Strong critical and strategic thinking skill and risk-based mindset.
• Proven track record of successful change management implementation across highly matrixed organizations.
• Ability to travel (up to 30%).

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible.