London, United Kingdom | full time | Job ID: 10151
About the role
As an Associate Director Clinical Quality Assurance at BioNTech, you play a pivotal role in ensuring the quality and compliance of our clinical development activities. You will be part of a dynamic, cross‑functional team that fosters innovation and collaboration while maintaining a proactive, risk‑based quality strategy. Join us to make an impact in a fast‑paced environment that values transparency, teamwork, and continuous improvement.
Your contribution
* Establish and implement proactive, risk‑based Quality Strategies for assigned clinical trials
* Collaborate with internal stakeholders to identify risks, investigate deviations, and develop robust Corrective and Preventive Actions (CAPAs) with effectiveness checks
* Maintain inspection readiness through dashboards outlining key quality aspects related to milestones
* Ensure adequate quality oversight of clinical activities with external partners such as CROs
* Facilitate Health Authority inspections preparation, support mock inspections, and oversee CAPA completion post‑inspection
* Mentor team members while contributing to continuous improvement initiatives within BioNTech
A good match
* University degree in life sciences
* 5–8 years of experience in a Good Clinical Practice (GCP)-regulated environment; 3–5 years in Quality Assurance (QA)
* Key understanding of global regulations and guidelines such as ICH, FDA, EMA related to clinical trial development
* Proficiency in managing escalations and CAPA advisement; inspection management experience preferred
* Strong collaborative skills within cross‑functional global teams; effective external stakeholder engagement
* Fluency in English (written and spoken); computer literacy including MS Office and electronic quality management systems
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 are 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.
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