Director of Quality

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.

Reporting to the Corporate Vice President, the Director of Quality will be responsible for the Keele Quality Group ensuring that operational activities are GMP compliant within the MHRA guidelines and activities are coordinated to meet customer deliverables alongside the Operations and Commercial groups. The Director of Quality will lead on all GMP related matters for the Keele site as well as being the prime point of contact with customers with respect to GMP and quality matters.

Main duties will include:

• Leadership on the Keele Quality Forum
• Representation at the Senior Management Team, with the provision of Quality updates to the Joint Management Team, when requested.
• Contribute to the strategic development of the site according to Local Management Team initiatives.
• Ensure that the Keele site operates to GMP, ensuring that MHRA compliance is maintained in accordance with the relevant European and where necessary, international guidelines.
• Work closely with Operations and Project Management to ensure that the scheduling of work within the Quality Group supports project timelines.
• Be proactive in developing and implementing harmonisation plans for Cobra Biologics Group so that each site operates in harmony from a Quality perspective, in particular with the customer facing documentation.
• Ensure that the employees of the Keele Site are fully aware of their GMP requirements and provide GMP training when required.
• Ensure that the Keele site has an appropriate internal auditing program.
• Work in close cooperation with Operations, Customers and Contract laboratories to optimise processes, help solve problems and assure quality.
• Coordinate/host Client and Regulatory audits.
• Drive the generation of audit responses and the timely implementation of corrective actions.
• Approve a range of quality documents (such as procedures, master batch records, completed batch records, laboratory methods, Deviations and Change Controls) or to delegate these approvals to suitability qualified members of the Quality Group.
• Be named on the Keele Manufacturing Licence with responsibility for ensuring that the respective regulatory requirements for batch release and certification are met.

You will be educated to degree level or equivalent in Chemistry, Biology or Pharmacy and have eligibility for membership of the Royal Society of Chemistry, the Institute of Biology or the Royal Pharmaceutical Society. You will have extensive experience in a similar quality leadership role and demonstrate a proven track record of managing multi-disciplinary teams and planning and executing deliverables within budget and to timescale. Previous experience of and able to demonstrate the ability to develop business objectives and contribute to strategic thinking is essential. Qualified Person status with previous commercial experience in a Biologics industry would be highly desirable.

In addition, you will have significant experience of leading large teams and be able to demonstrate strong verbal and written communication and presentation skills.

This role will be based at Keele, Staffordshire, however, the role will require regular travel within the Group.

Applications should be sent in writing stating the appropriate reference number with full CV and current salary details via the form below.