Manager Operational Quality Assurance | Biologe (m/w/d)

BioNTech SE

Mainz am Rhein, Rheinland-Pfalz, Deutschland
Published Jul 23, 2025
Full-time
No information

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

German (Fluent)English (Fluent)

Additional

  • Not specified