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Quality Assurance Lead


Quality Assurance Lead - Fixed Term Contract

CK Science are currently recruiting for an experienced Quality Assurance Lead on a 21-month Fixed Term Contract, at our client's site near Hitchin.

My client's vision has always been for the UK to be a global leader in the development, delivery and commercialisation of cell and gene therapies and a place where collaborating businesses can start, and confidently grow.

With a custom-built research and manufacturing faculties, with more than 170 employees focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. The overall aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies.

Your main responsibility for this role is to manage PQS revision to demonstrate compliance with US cGMPs, as the company embarks on their next stage of development to export cell and gene therapy products to the US.

Additional Responsibilities:

  • Report directly to the Head of Quality Assurance with close interaction with the manufacturing centre management team.
  • Develop a US cGMP compliance strategy for the manufacture centre.
  • Lead collaborations with subject matter experts to deliver a US cGMP compliant PQS.
  • Identify all relevant US cGMP standards application to activities within the manufacturing centre.
  • Lead and execute US cGMP mock inspection programmes to demonstrate project success.

Your Background:

  • Experience in interacting with regulatory authorities, specifically the US FDA
  • Knowledge of EU/MHRA and FDA regulatory requirements, ideally for cell and gene therapy products.
  • Practical experience in leading/hosting US FDA GMP inspections.

Entitlement to work in the UK is essential. For more information, please contact James and the Life Sciences Team on 01246 457722 or email [email protected] Please quote reference 47763 in all correspondence.

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Stevenage, England, Hertfordshire, SG1, United Kingdom

  • Ad ID:  14888938
  • Ad Type:  Offered
  • Posted on:  03/07/2020, 02:52
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