Manager Operational Quality Assurance | Biologe (m/w/d)
BioNTech SE
Job Summary
As a Manager of Operational Quality Assurance in Quality Control, you will play a crucial role in ensuring the quality of clinical trial samples. You will be a key member of the OQA Manufacturing and Quality Control team in Mainz, Germany, contributing to the highest quality standards for clinical studies and ensuring product safety and efficacy. Your day-to-day responsibilities will involve providing QA support for the release analytics of clinical trial preparations, acting as a primary contact for quality-related issues, and ensuring compliance with GMP guidelines and the Quality Manual. You will review and approve deviations, non-conforming results, and change requests, while actively participating in inspections and audits. This role is ideal for a professional with a scientific background and significant experience in the pharmaceutical industry, particularly with a strong understanding of GMP regulations and quality system optimization.
Required Skills
Education
Completed scientific degree or completed medical-technical training or comparable qualification
Experience
- More than 5 years of professional experience in the pharmaceutical industry or Quality Control
- Experience in Quality Control of ATMP (Advanced Therapy Medicinal Products) and IMP (Investigational Medicinal Products) is desirable
- Experience in implementing and optimizing quality systems
Languages
Additional
- Not specified
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