As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.
We are currently looking to recruit a Head of Quality Control & Analytics responsible for day-to-day management of a multifunctional team to deliver QC & Analytics services within a cGMP environment.
Reporting to the Director of Quality, the main duties will include:
- Line management and responsibility for the site QC and Analytics Team, including recruitment, training and coaching of staff in industry best practice
- Scheduling, management and time driven delivery of QC analytical and microbiological services including: QC release (raw materials, intermediates, cell banks, bulk and drug product) stability, EM compliance and trending, process and product evaluation, method development, transfer, optimisation, qualification and validation
- Supporting the Director of Quality in regulatory and client audit activities
- Working closely with the Operations, Quality Assurance and Project Management teams to ensure that scheduling of work within QC supports project timelines without compromising compliance
- Managing QC efficiency, improvement and capital projects
You will be educated to degree level or equivalent in a Scientific discipline, with extensive relevant pharmaceutical experience in a biologics environment. Previous experience in analytics management, including demonstrable knowledge of relevant techniques and systems is essential. In addition, you will have previous management experience of multi-disciplinary teams. Experience in client and regulatory authority audit preparedness and post audit observation management is also a requirement of the role.
You will interact well 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 expected to interact in a technical and compliance capacity with clients during face to face and telecom meetings.
You will be a proactive team player within the department and across the organisation, who demonstrates drive and initiative, and has a successful track record in effecting system and cultural change.
The position will be based at Keele, Staffordshire however, willingness to travel within the Group and for audit and client meetings will be required.