Director, Central Quality Audit

Managing, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

Roles and Responsibilities

• 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, elevate findings, and provide actionable recommendations to senior leadership.