London, United Kingdom; Mainz, Germany; Munich, Germany | full time | Job ID: 11320
About the Role:
As Associate Director Audit Management, you will play a pivotal role in ensuring the quality and compliance of BioNTech’s clinical trials and processes. As part of the Global Development Quality Assurance team, you will lead audits across Good Clinical Practice (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practice (GVP), and Information Technology (IT) domains. Your work will directly contribute to advancing BioNTech’s mission by ensuring adherence to regulatory standards and fostering continuous improvement in clinical development activities.
Your Contribution:
* 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
Additionally:
* 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
A Good Match:
* 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
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.