Cobra Biologics, now a Charles River company, is a leading international contract development and manufacturing organization (CDMO) specializing in premium plasmid DNA and viral vector services to support the Advanced Therapy Medicinal Products (ATMP) industry.  Each of our GMP approved facilities are tailored to serving clients from early stage, to clinical, to commercial scale. Our team takes pride in manufacturing excellence and supporting drug development for the benefit of patients worldwide.  Our mission is to continue to expand and cultivate our CDMO offerings in the cell and gene therapy space, providing supply chain simplification through an end-to-end service for development, testing, and manufacturing. We provide our clients with an integrated solution from basic research and discovery through to GMP production.

We are currently looking to recruit a Quality Leader (Systems) responsible for day-to-day GMP quality system compliance at the Keele facility. Reporting to the Head of Quality Assurance, the successful candidate will be required to work closely with the Operations, Quality Control and Project Management teams to actively manage quality system action closure and quality systems development and optimisation.

Main duties will include:

  • Supporting the Head of Quality Assurance in proactively managing and driving quality systems action closure within defined timelines, and in developing and implementing user friendly quality system improvements in compliance with MHRA requirements.
  • Providing continuous trending of key quality metrics for regular presentation to senior site management, and identifying methods of improvement.
  • Responsibility for planning, execution and maintenance of internal and external audit systems.
  • Application of suitable risk-based quality system techniques to resolve operational challenges to deliver product of the required quality.
  • Review and approval of a wide range of quality documents.
  • Supporting, when necessary, QA Team Leaders to deliver on time products and processes in compliance with current GMP and regulatory guidelines.
  • Co-ordination of regulatory and client audit preparedness activities, management of audit responses and action closure.
  • Supporting the Head of Quality Assurance in regulatory and client audit hosting.
  • Line management of the Quality Assurance Systems Team, including training, mentoring and coaching of staff in industry best practice QA ways of working.

You will be educated to degree level or equivalent in a Science subject, or have significant relevant Pharma experience in a manufacturing or quality assurance role. A successful track record in the proactive management/championing of quality systems action closure and systems improvement is essential. Experience in quality risk management techniques is essential, with use of FMEA being desirable. Experience of biologics is preferable, but not essential.

In addition, you will have previous supervisory experience and have spent some time working within R&D and/or the manufacture of clinical products. Experience in audit preparedness and post-audit observation management is desirable, as is experience in developing and delivering programmes of GMP training.

You will interact at all levels of the organisation and be able to demonstrate strong communication, interpersonal and organisation skills in order to work constructively in a fast-moving environment. You will also be a proactive team player, within the department and across the organisation, who is willing to adopt and implement change. Demonstrating independent thinking, decisiveness and being a self-starter is also essential.

The position will be based at Keele, Staffordshire however, willingness to travel within the Group will be required.

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