Director

• 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.

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Director, Central Quality Audit, Pharmacovigilance