Regional Clinical Audit Director – EMEA

This is a fully remote position, open to applicants in United Kingdom, +1 more state.

📋 Description

• Spearhead the design and execution of a clinical risk-based audit program throughout Europe, the Middle East, and Africa, ensuring compliance with regulatory authority standards while utilizing various innovative audit methodologies.

• Assemble, guide, and mentor a team of auditors to deliver uniform, high-caliber audits and effective follow-up procedures.

• Contribute strategic insights toward the formulation, management, and execution of strategies, policies, and procedures that bolster the audit program.

• Establish and nurture productive working relationships with both internal and external stakeholders, as well as within the R&D Quality and Risk Management matrix.

• Analyze metrics, trend reports, and insights to determine risk priorities and enhance control measures.

• Assist in ensuring inspection readiness, managing regulatory interactions, and investigating significant compliance issues.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Pharmacy, Health Sciences, or a related field (or equivalent professional experience).

• Background in the scientific or pharmaceutical industry with experience in clinical trials.

• Familiarity with global, regional, and national regulatory frameworks and guidelines.

• Proven experience in conducting risk-based audits of internal operations and third-party suppliers.

• Experience in leading and developing audit teams across various locations.

• Strong project management capabilities and the ability to oversee complex cross-functional initiatives.

• Excellent verbal, written, and presentation skills with the ability to influence and negotiate with senior stakeholders.

• Capacity to operate independently and make decisions with minimal oversight.

• Strong interpersonal skills, with the ability to collaborate within a matrix across geographical and organizational boundaries.

🏝️ Benefits

• Competitive salary

• Annual bonus

• Share-based long-term incentive program