As a leading manufacturer of Biopharmaceuticals, Cobra Biologics is dedicated to designing robust processes for its international life science customers that deliver quality commercial, clinical, and pre-clinical products. To comply with the rigorous Regulatory requirements of today our flexible and resourceful teams devise innovative, streamlined and optimised solutions to overcome the hurdles in manufacturing proteins, viruses, DNA, and cell products. All our programmes meet cGMP standards worldwide with full Regulatory support.
We are currently looking to recruit a Quality Assurance Manager responsible for day-to-day GMP compliance at the Keele facility. Reporting to the Quality Director, the successful candidate will be required to work closely with the Operations and Project Management teams to actively manage Quality System action closure, Quality Systems development and optimisation, help solve problems and assure quality and compliance for all customer requirements.
The main duties will include:-
• Line management and responsibility for the site Quality Assurance Team, including coaching of staff in industry best practice QA ways of working
• Management and evolution of the site Quality Management Systems; developing and implementing user friendly Quality System improvements in compliance with relevant Regulatory Authorities (e.g. MHRA and FDA) and Industry requirements
• Management of the site Supplier Assurance and Validation Systems
• Review and approval of a wide range of Quality documents
• Supporting the Quality Director in Regulatory and Client audit activities
• Interaction with Operations and Project Management to ensure customer deadlines are met without compromising quality and compliance
The ideal applicant will possess a Science degree or equivalent, or have at least 10- years 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.
In addition, He/She will have previous management experience and have spent time working with both Clinical and Commercial Quality Systems and products. Experience in audit preparedness and post-audit observation management is desirable, as is experience in developing and delivering programmes of GMP training. Experience of biologics is preferable, but not essential.
The individual will be expected to 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. He/She will need to be a proactive team player, within the department and across the organisation, who is willing to adopt and implement change. The successful candidate needs to demonstrate independent thinking, be decisive and be a self-starter.
The position will be based at Keele, Staffordshire however, willingness to travel within the Group will be required.
Applications should be sent in writing stating the appropriate reference number with full C.V. and current salary details to: Sheena Pumford, Human Resources Director, using the form below.