Director, GVP Audits

Role Summary

As a Director, GVP Audits, you will lead Gilead’s pharmacovigilance audit program, drive audit excellence, and ensure global compliance across pharmacovigilance processes. You will oversee internal GVP audits, support the E-System/Digital audit program, and manage complex audits across R&D functions, external vendors, and critical PV workstreams. The role requires collaboration with cross-functional stakeholders and proactive management of pharmacovigilance compliance risks.

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. Serves 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.
• 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.
• 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.
• Develop and deliver GVP audit training for assigned R&D quality groups and targeted GVP audit and audit skill training; foster collaboration and knowledge sharing with key stakeholders.
• Lead and participate in regulatory inspections as needed and actively contribute to inspection readiness.

Qualifications

• PharmD/PhD with 8+ years of GVP auditing or related experience OR
• MA/MS/MBA with 10+ years of GVP auditing or related experience OR
• BA/BS with 12+ years of GVP auditing or related 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.
• 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.
• Proven abilities to assume increasing scope and complexity, with prior successes in team and project leadership, strategic cross-functional partnering, and contributions to strategy and operations.
• Advanced business knowledge and analytical skills, with ability to assess complex information and understand quality and compliance implications.
• Track record of successful interaction and collaboration with other functions and senior leadership on key quality and compliance projects.
• Demonstrates ability to execute against strategic and tactical objectives provided by senior leaders within and outside Quality.
• Demonstrates ability to integrate varied concepts and data to develop relevant solutions.
• Proven abilities to anticipate problems of varying complexity and lead resolution in a collaborative manner across functions.
• Strong leadership presence with ability to influence programs without formal authority.
• Strong critical and strategic thinking with a risk-based mindset.
• Proven track record of successful change management across highly matrixed organizations.
• Ability to travel up to 30%.

Education

• US Education & Experience: PharmD/PhD with 8+ years of GVP auditing or related experience; MA/MS/MBA with 10+ years; BA/BS with 12+ years.
• Rest Of World Education & Experience: BA/BS or advanced degree in life sciences or related field with significant relevant experience in the biopharma industry, including quality, compliance, pharmacovigilance, or related field; extensive GVP audit leadership experience.

Additional Requirements

• Ability to travel up to 30%.