Overview

Associate Director, Good Pharmacovigilance Practice (GVP) Audits – role at Gilead Sciences.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. This role requires collaboration with cross-functional stakeholders to execute internal GVP audits, support E-System/Digital audits, and lead complex audits across RandD, vendor, and pharmacovigilance workstreams. Reporting to the Head of GVP Audits, the Associate Director contributes to the strategic development and operational execution of the GVP audit function.Key objectives include maintaining global compliance, shaping the RandD Quality Annual Audit Program, and driving CAPA effectiveness through quality forums and internal communications.Primary Responsibilities

GVP Audit Program: Oversee and complete a broad spectrum of GVP audit activities and deliverables across affiliates, partners, vendors and internal PV processes.Lead internal RandD quality audits for assigned RandD groups or locations.Provide subject matter expertise and support to project teams.Develop, drive, or support continuous improvements in RandD quality processes, systems, and standards to meet regulatory requirements and organizational goals while contributing to a quality-minded culture.GVP Audit Operations

Serve as primary point-of-contact to assigned RandD groups; advise on GVP regulatory requirements, evolving legislation, and Gilead policies and procedures supporting audits and pharmacovigilance.Execute the strategic audit plan; plan, schedule, and conduct GVP audits per plan.Prepare and deliver high-quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.Collaborate with RandD Quality Business Partners and SME stakeholders.Support risk assessment activities in partnership with risk program and SMEs.Support overall inspection readiness of the GVP Audit program, including preparation for and participation in inspections.Oversee and manage contractor auditors, ensuring effective oversight and completion of tasks.Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.Support E-Systems/Digital Audit program as needed and maintain awareness of industry trends.Quality Management

Evaluate, advise on systems, processes, documentation, and CAPAs for assigned RandD groups to ensure ongoing compliance with regulatory requirements.Prepare assigned RandD groups for inspections or external reviews in alignment with Gilead business needs and regulatory requirements.Stay current with evolving global PV regulations and guidance.Support development of GVP Audit materials/insights for quality forums and management reviews.Training and Development

Develop and deliver GVP training for assigned RandD groups to maintain compliance and audit excellence.Establish relationships with key stakeholders to facilitate training, knowledge sharing, and continuous improvement initiatives.Education and Experience

BA/BS or advanced degree in life sciences or related field with significant experience in biopharma, including quality, compliance, pharmacovigilance, or related areas. Extensive experience leading GVP audits in biopharma or related industry.Knowledge and Other Requirements

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 track record of leading pharmacovigilance audits.Strong understanding of QA systems, standards, policies, and CAPA processes to ensure compliant operations.Ability to make independent decisions on relatively complex projects and issues; proven leadership in matrixed environments and cross-functional collaboration.Strong critical and strategic thinking with a risk-based mindset.Track record of driving change management across highly matrixed organizations.Ability to travel up to 30%.EEO Statement: It is the policy of Gilead Sciences, Inc. to recruit, select, and employ the most qualified persons for positions throughout the Company on a non-discriminatory basis. Gilead prohibits discrimination based on protected characteristics and complies with applicable laws.For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.

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