Director, GVP Audits
Gilead Sciences
1 month ago
On-site
Parsippany, NJ
$191,250 - $247,500 USD yearly
Operations
Job Description (Director, GVP Audits)
- Play a leadership role within Gilead’s R&D Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities.
- Lead strategic execution of internal GVP audits; support the E-System/Digital audit program.
- Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance workstreams/processes.
- Collaborate with cross-functional stakeholders (R&D Quality Business Partners, Patient Safety, QPPV) to identify, evaluate, and mitigate pharmacovigilance compliance risks.
- Responsible for the GVP Audit Master Index and strategic/operational activities of the GVP Risk-based Audit process (Annual and Long Range Plans).
- Reporting to the Head of GVP Audits: develop audit tools/procedures, optimize resource planning, ensure CAPA effectiveness, and provide updates through quality governance forums.
- Support regulatory inspections and R&D inspection readiness; partner to build quality capabilities, drive process improvements, and foster a culture of compliance and continuous improvement.
Responsibilities
- GVP Audit Program Leadership
- Oversee completion of GVP audit activities/deliverables across affiliates, partners, vendors, and internal PV processes.
- Drive and enhance the GVP Risk-Based Audit Approach (long-range/annual plans); serve as Process Owner for related documentation, strategy materials, and risk assessments.
- Lead internal R&D Quality audits for assigned R&D groups/locations.
- Drive continuous improvement of audit processes, systems, and standards.
- Serve as a trusted advisor to senior stakeholders on GVP compliance and audit strategy.
- GVP Audit Operations
- Serve as primary point-of-contact for assigned R&D groups; provide expert guidance on GVP regulatory requirements and Gilead policies/procedures.
- Plan, schedule, and conduct the annual GVP audit plan.
- Deliver audit reports; ensure timely CAPA closure and effectiveness checks.
- Collaborate with R&D Inspection Management, QBPs, and SMEs to prepare PV partner audits from external partners.
- Lead/support risk assessment activities with risk management teams.
- Support inspection readiness and participate in regulatory inspections as required.
- Oversee contractor auditors to ensure quality and timely delivery.
- Support the E-Systems/Digital Audit program as needed.
- Maintain an external network to stay current on industry trends.
- Quality Management
- Evaluate systems, processes, and documentation for ongoing compliance and continuous improvement.
- 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/guidance and translate into actionable strategies.
- Provide insights/updates for quality forums and management reviews.
- Training & Development
- Develop and deliver GVP audit training for assigned R&D quality groups.
- Develop and deliver targeted GVP audit/audit-skill training for the GVP Audits team.
- Build relationships with contract auditors and functional leaders to foster collaboration and knowledge sharing.
Required Education & Experience
- 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)
(For Rest of World) Education & Experience
- BA/BS or advanced degree in life sciences or related field with significant biopharma industry experience in quality/compliance/pharmacovigilance (or related); extensive experience leading GVP audits.
Knowledge & Other Requirements (Required/Preferred)
- Proficiency in global pharmacovigilance regulatory requirements (required).
- Expert-level experience with GVP processes and systems (required).
- Proficient in GxP Auditing with a successful track record leading pharmacovigilance audits.
- Broad cross-functional experience tied to pharmacovigilance and quality system activities.
- Significant experience leading quality/compliance (or related) projects in biopharma, including continuous improvements (processes/systems/SOPs).
- Experience with total quality management methodologies such as Lean Six Sigma (preferred).
- Certification as a Quality Auditor (preferred).
- Expert knowledge of drug development process and GVP, including FDA, EMA, ICH and application to cross-functional drug development.
- Thorough knowledge of QMS standards/systems/policies/procedures enabling biopharma compliance specifically related to GVP.
- Proven ability to make appropriate independent decisions on complex issues.
- Proven ability to assume increasing scope/complexity; demonstrated leadership, strategic partnering, and contributions to strategy/operations/infrastructure.
- Advanced analytical/business skills assessing complex information and quality/compliance implications.
- Track record collaborating with other functions and senior leadership.
- Ability to execute strategic/tactical objectives; integrate concepts/data into solutions.
- Ability to anticipate and lead resolution of problems across functions.
- Strong leadership presence; ability to lead without authority and influence programs/projects.
- Strong critical/strategic thinking with a risk-based mindset.
- Proven change management in highly matrixed organizations.
- Ability to travel (up to 30%).
Location
- Parsippany, NJ / Stockley Park, UK / Cambridge, UK (ideally local to site).
Benefits
- Salary range: $191,250.00 - $247,500.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.
- Play a leadership role within Gilead’s R&D Quality Organization, driving audit excellence and ensuring global compliance across pharmacovigilance activities.
- Lead strategic execution of internal GVP audits; support the E-System/Digital audit program.
- Oversee complex audits across broader R&D functions, external vendors, and critical pharmacovigilance workstreams/processes.
- Collaborate with cross-functional stakeholders (R&D Quality Business Partners, Patient Safety, QPPV) to identify, evaluate, and mitigate pharmacovigilance compliance risks.
- Responsible for the GVP Audit Master Index and strategic/operational activities of the GVP Risk-based Audit process (Annual and Long Range Plans).
- Reporting to the Head of GVP Audits: develop audit tools/procedures, optimize resource planning, ensure CAPA effectiveness, and provide updates through quality governance forums.
- Support regulatory inspections and R&D inspection readiness; partner to build quality capabilities, drive process improvements, and foster a culture of compliance and continuous improvement.
Responsibilities
- GVP Audit Program Leadership
- Oversee completion of GVP audit activities/deliverables across affiliates, partners, vendors, and internal PV processes.
- Drive and enhance the GVP Risk-Based Audit Approach (long-range/annual plans); serve as Process Owner for related documentation, strategy materials, and risk assessments.
- Lead internal R&D Quality audits for assigned R&D groups/locations.
- Drive continuous improvement of audit processes, systems, and standards.
- Serve as a trusted advisor to senior stakeholders on GVP compliance and audit strategy.
- GVP Audit Operations
- Serve as primary point-of-contact for assigned R&D groups; provide expert guidance on GVP regulatory requirements and Gilead policies/procedures.
- Plan, schedule, and conduct the annual GVP audit plan.
- Deliver audit reports; ensure timely CAPA closure and effectiveness checks.
- Collaborate with R&D Inspection Management, QBPs, and SMEs to prepare PV partner audits from external partners.
- Lead/support risk assessment activities with risk management teams.
- Support inspection readiness and participate in regulatory inspections as required.
- Oversee contractor auditors to ensure quality and timely delivery.
- Support the E-Systems/Digital Audit program as needed.
- Maintain an external network to stay current on industry trends.
- Quality Management
- Evaluate systems, processes, and documentation for ongoing compliance and continuous improvement.
- 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/guidance and translate into actionable strategies.
- Provide insights/updates for quality forums and management reviews.
- Training & Development
- Develop and deliver GVP audit training for assigned R&D quality groups.
- Develop and deliver targeted GVP audit/audit-skill training for the GVP Audits team.
- Build relationships with contract auditors and functional leaders to foster collaboration and knowledge sharing.
Required Education & Experience
- 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)
(For Rest of World) Education & Experience
- BA/BS or advanced degree in life sciences or related field with significant biopharma industry experience in quality/compliance/pharmacovigilance (or related); extensive experience leading GVP audits.
Knowledge & Other Requirements (Required/Preferred)
- Proficiency in global pharmacovigilance regulatory requirements (required).
- Expert-level experience with GVP processes and systems (required).
- Proficient in GxP Auditing with a successful track record leading pharmacovigilance audits.
- Broad cross-functional experience tied to pharmacovigilance and quality system activities.
- Significant experience leading quality/compliance (or related) projects in biopharma, including continuous improvements (processes/systems/SOPs).
- Experience with total quality management methodologies such as Lean Six Sigma (preferred).
- Certification as a Quality Auditor (preferred).
- Expert knowledge of drug development process and GVP, including FDA, EMA, ICH and application to cross-functional drug development.
- Thorough knowledge of QMS standards/systems/policies/procedures enabling biopharma compliance specifically related to GVP.
- Proven ability to make appropriate independent decisions on complex issues.
- Proven ability to assume increasing scope/complexity; demonstrated leadership, strategic partnering, and contributions to strategy/operations/infrastructure.
- Advanced analytical/business skills assessing complex information and quality/compliance implications.
- Track record collaborating with other functions and senior leadership.
- Ability to execute strategic/tactical objectives; integrate concepts/data into solutions.
- Ability to anticipate and lead resolution of problems across functions.
- Strong leadership presence; ability to lead without authority and influence programs/projects.
- Strong critical/strategic thinking with a risk-based mindset.
- Proven change management in highly matrixed organizations.
- Ability to travel (up to 30%).
Location
- Parsippany, NJ / Stockley Park, UK / Cambridge, UK (ideally local to site).
Benefits
- Salary range: $191,250.00 - $247,500.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.