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Head of Quality


  Frankfurt,   £80000 - £100000

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  Quality    Permanent

Vacancy Details

I am recruiting on behalf of an innovative Gene therapy company . The company are entering an exciting time of growth and require an intuitive individual to help them put the correct structure and culture into place.

You will play a key role in establishing, growing and maintaining the quality systems and processes to support the expansion of operations for GMP production. This is an excellent opportunity for someone looking to join a developing business at a pinnacle time of growth.

 

Location: This role could be based at a number of sites in Germany or Switzerland.

 

Responsibilities:

  • Manage day to day activities of the Quality Assurance department and be the reference QA person for all company activity.
  • Be responsible for all quality assurance activities, e.g. GxP (Good laboratory, clinical, manufacturing, distribution and documentation practices), company SOPs and policies, QA validation activities and compliance training.
  • Oversee QA for all GMP activity including batch record review to ensure that controlled documents are followed, standards of quality are maintained, and documentation is complete.

Requirements:

  • Advanced degree preferred, e.g. MS or PhD in chemistry, cell biology, pharmacology, pharma-cy or closely related field
  • Minimum of 10 years’ experience in working in a pharmaceutical / biotechnology field.
  • Extensive experience working in a GMP environment, preferably in the field of ATMPs
  • A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
  • QP experience is desirable

Looking but this isn’t the right position for you?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to joe.lane@catalystcareers.com or call +49 6995 179960 for a confidential discussion about potential opportunities.

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