Gilead Sciences · 1 day ago
Director, GVP Audits
Parsippany, NJ
Full-time
Onsite
Director/Executive
$191K/yr - $248K/yr
8+ years expGilead Sciences is a biopharmaceutical company dedicated to creating a healthier world by tackling major diseases. The Director, GVP Audits will lead audit excellence within the R&D Quality Organization, ensuring compliance across pharmacovigilance activities and overseeing complex audits while collaborating with cross-functional stakeholders.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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
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
Qualification
Required
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
Proficiency in pharmacovigilance regulatory requirements (Global)
Expert-level experience working with GVP processes and systems
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
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%)
Preferred
Experience working with total quality management methodologies, such as Lean Six Sigma
Certification as a Quality Auditor
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-09
2026-01-08
2026-01-07
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