Director Clinical Quality Assurance Compliance | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This senior leadership role requires a Director of Clinical Quality Assurance Compliance to spearhead quality activities across global clinical development programs, ensuring strict adherence to Good Clinical Practice (GCP) and regulatory standards. The director will be responsible for developing and executing a proactive, risk-based quality strategy for high-priority trials, ensuring continuous inspection readiness, and managing quality agreements with external vendors like CROs. A key component of the role involves collaborating with internal and external partners to identify and remediate clinical trial risks, including managing CAPAs. This position requires profound professional experience, strong GCP expertise, and proven ability to lead and develop a team within a regulated environment. Success in this role hinges on acting as an ambassador for quality, driving continuous improvement, and supporting the delivery of the clinical trial portfolio across the Global Development Organization.
Required Skills
Education
University degree in Life Sciences
Experience
- Beyond 10 years in a GCP-regulated environment
- Professional experience in a senior Quality Management and/or Clinical Operations role
- Experience in team leadership and development
- Experience managing, hosting, or supporting regulatory authority inspections (EMA/FDA/MHRA)
Languages
Additional
- Not specified
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