Biologist / Quality Management Specialist | Biologe (m/w/d)

Zedira GmbH

Darmstadt, Hessen, Deutschland
Published Mar 9, 2026
Full-time
No information

Job Summary

This role at Zedira, a specialized biotechnology company in Darmstadt, focuses on the strategic expansion of the existing Quality Management System (QMS) toward full GMP compliance. As a Biologist or Quality Management Specialist, you will be responsible for the day-to-day maintenance of ISO-standard quality systems while actively building, implementing, and documenting a new GMP framework. Key tasks include creating and managing SOPs, validation documents, and conducting internal and external audits. You will also serve as a trainer for staff on QM and GMP topics. This position is particularly attractive for professionals who enjoy shaping processes from the ground up and want to work at the intersection of research, production, and management. You will have a direct impact on the development of specialized reagents and drug candidates for conditions like celiac disease and thrombosis within a collaborative, international environment characterized by short decision-making paths.

Required Skills

Education

University degree in natural sciences (e.g., Biotechnology, Biology, or Chemistry)

Experience

  • Comprehensive professional experience in Quality Management including GMP requirements
  • Experience in the development and maintenance of ISO-standard quality systems
  • Experience in creating, checking, and managing SOPs and validation documents
  • Experience conducting audits and providing employee training

Languages

German (Fluent)English (Fluent)

Additional

  • Must be willing to work on-site in Darmstadt; requires the ability to take responsibility for building a GMP-compliant system from scratch.