Director Quality Assurance and Regulatory Affairs

vor 6 Monaten


Duesseldorf, Deutschland Meet Recruitment Vollzeit

100000 EUR - 150000 EUR
- Cologne, Germany
- Permanent

**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.

**Responsibilities**:

- 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

**Profile**:

- 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



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