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

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

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 – Clinical Quality Assurance

Key skills