Director, GVP Audits

Gilead Sciences, Inc.; Uxbridge; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company in the United Kingdom seeks a professional to play a leadership role in R&D Quality Organization. The successful candidate will drive audit excellence, manage GVP audits, and ensure global compliance in pharmacovigilance. Responsibilities include overseeing audits, collaborating with stakeholders, and providing expert guidance. Candidates must have significant experience in the biopharma industry, strong leadership skills, and a comprehensive understanding of regulatory requirements. This position offers opportunities for talent development and team empowerment.

Qualifications

• Significant relevant experience in the biopharma industry.
• Extensive experience leading GVP audits.
• Proficient in pharmacovigilance regulatory requirements.
• Expert knowledge of drug development process and GVP.

Responsibilities

• Drive audit excellence and ensure global compliance.
• Lead GVP audits and deliver high quality audit reports.
• Collaborate with stakeholders for audit preparation and execution.
• Develop and deliver GVP audit training for quality groups.

Skills

GVP regulatory requirements

Pharmacovigilance experience

Leadership and influence

Analytical skills

Change management

Education

BA/BS or advanced degree in life sciences

Job description

* 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 workstreams 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, 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%)* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.