One of the world's leading Biotech companies is urgently looking to hire an experienced Quality Head who can take over Quality leadership of their brand new site in Marburg.
Key responsibilities of the Quality Head include:
- Develops and implements quality-wide and site-specific strategies based on the overall Quality and Biotechnology objectives
- Responsible that drug substance is manufactured in compliance with all applicable internal external regulations
- Ensure a fit-for-purpose quality organization
- Seeing ahead to future possibilities and translating them into breakthrough strategies
- Responsible for overall relationships with regulatory and health authority bodies
- Maintains quality on the basis of actual data of Quality Assurance
- Execution of all assigned activities in accordance with applicable GMP-, labor-, workplace-, environment- and safety instructions and -regulations
- Excellent documentation of activities in accordance with GMP regulations
- Willingness for continuous improvement and deficiency analysis
- Participation in all trainings which are applicable for the role, maintenance of respective training records
- Promotion of an HSE suitable environment: Reporting of near misses, if required
- Qualified Person (according to Medicinal Products Act - AMG §15)
Key requirements of the Quality Head include:
- Minimum Master Degree (preferably PhD) in Science (Chemistry, Biology, Pharmaceutics)
- Minimum 10 years of experience in different quality functions (QA Operations, Quality Control) in pharmaceutical industry
- Experience working in a multi-national, multi-cultural corporation
- Fluent English and German language skills
