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.
Requirements
- 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
Benefits
- competitive remuneration packages