Lead global audits with a focus on clinical investigator sites and vendor audits in the EU, UK, and surrounding regions
Ensure audit objectives align with risk-based strategies to uphold quality standards
Coordinate and oversee audits conducted by contracted auditors, including scheduling, resource selection, and report reviews
Execute audits as the lead auditor for non-contracted audits (remote or on-site)
Develop robust Corrective and Preventative Action (CAPA) plans, track their completion, and assess effectiveness
Monitor trends in audit observations to identify areas for improvement
Manage projects and relationships with audit vendors while supporting local health authority inspections
Drive continuous improvement initiatives within audit management processes

Academic degree in Life Sciences; advanced degree preferred (e.g., Master’s level)
At least 10 years of clinical trial experience, including 6 years in clinical auditing within the region
Proven leadership experience managing teams or projects for at least 3 years
Deep knowledge of global GCP regulations and quality audit methodologies; oncology experience is an advantage
Proficient in Microsoft Office software, Veeva, SharePoint; excellent English communication skills (written & verbal)
Willingness to travel up to 10% of the time.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.

Associate Director – Audit Management

Key skills