Director Quality Assurance and Regulatory Affairs
We are partnering with an exciting small biotech focused on the research, manufacturing and commercialisation of biopharma/biological products across different therapeutical areas. Being part of a international group, they are well stablished on the market and fast growing, working with a number of clients.
They are currently looking for a Director for their QA/RA department, who could also work as a QP on the release of their batches.
- Maintenance and further development of their QMS
- Conduction of internal and external audits, as well as participation on inspections
- Preparation and revision of authorisation dossiers - Module 3
- Working on SOP development
- Leading a small team
- Pharmacy or a Life Sciences related degree
- At least 5 years of QA experience in the industry - working with biologics
- Experience in Regulatory Affairs areas
- Ideally certification as a QP
Please contact me on +49 30 767580487 or email@example.com if you would like to know more about this opportunity. This will be a 100% confidential conversation.