Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices.
Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates.
Fully participate in the audit program; actively owning and executing PV audits.
Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership.
Regulatory Inspection Support: Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up.
Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership.
System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation.
Team Leadership: Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management.
Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement.
Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization.

Minimum 5 years of people leadership experience, including team development and performance management.
Qualified Lead Auditor with active certification.
Master’s degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor’s degree and 10+ years relevant experience.
Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly).
Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP.
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Prior Veeva and TrackWise Digital experience a plus.
Prior health authority experience a plus.
IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt).
Extensive experience in the Medica Device and Pharmaceutical industry.
Understanding of product quality improvement using tools such as Six Sigma, DFR.
Demonstrated ability to analyze and resolve problems.
Exceptional conflict-resolution skills.
Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
Demonstrated ability to lead programs/projects.
Ability to prioritize and drive multiple programs.
Strong oral and written communication skills in English.

Director, Central Quality Audit, Pharmacovigilance

Key skills