Director, GVP Audits

* Play a leadership role within Gilead’s R&D Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities
* Are responsible for the strategic execution of internal GVP audits and supports the E-System/Digital audit program
* Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance work streams and processes.
* 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.
* 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.
* 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.
* Proficient in GxP Auditing with a successful track record of leading pharmacovigilance audits.
* 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,…