Director Quality Assurance and Regulatory Affairs

138946
  • 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

 

Please contact me on +49 30 767580487 or millene@peoplewithchemistry.com if you would like to know more about this opportunity. This will be a 100% confidential conversation.

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