Director, GVP Audits
Gilead Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • United Kingdom
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Job Level
About the role
- 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.
- 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.
- 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.
- Support the overall inspection readiness of the GVP Audit programs, and actively participate in regulatory inspections as required.
- Maintain an external network to assure current understanding of industry trends.
Requirements
- 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.
- 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%)
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GVP auditspharmacovigilanceGxP Auditingtotal quality managementLean Six Sigmaaudit reportingCAPA closureregulatory compliancedrug development processquality system activities
Soft skills
leadershipstrategic thinkingcollaborationdecision-makingproblem-solvingchange managementanalytical skillscommunicationinfluence without authoritycontinuous improvement
Certifications
Quality Auditor certification