QC Operations Manager - Hertfordshire
Jason Johal is recruiting for an experienced Quality Control Operations Manager to join a multinational clinical-stage cell & gene therapy research company focused on the development and commercialisation of gene therapies for debilitating disorders based on a next-generation AAV gene therapy platform. This is a permanent role based in Hertfordshire (20 minutes North of London via train) and offers an excellent salary of £50,000 - £55,000 plus a good benefits package.
The Company: The organisation has a strong reputation for their technical and strategic expertise within the cell and gene therapy market across Europe. They place a strong emphasis on innovation, the ability to make a difference to patients lives and enabling staff to apply their skills whilst developing by collaborating within a multidisciplinary team. They will provide you with promising and exciting research projects in an environment that strongly values your development. Their gene therapy treatment builds upon their own pioneering work and their proprietary AAV capsid which is optimised to effectively transduce human liver cells and thus provide sustainable, high levels of the desired protein.
The Role: You will work closely with the Director of Quality Control in the establishment, development and operation of the systems and processes for QC capability covering both in-house and external testing, in GMP and GCP arenas. You will also work with the QC function heads and Project leads to establish and operate planning processes for short, mid and long-term testing, introduction of technological advances and capacity creation. Responsibilities will include coordinating and managing QC service provision for product development programs, developing and tracking KPIs for critical business deliverables and planning and executing projects to establish and expand new internal lab services and capacity.
Further responsibilities will include developing and maintaining systems for managing contracts and budgets for external testing at 3rd party suppliers, driving development and implementation of policies and procedures, working with QA to ensure optimal design of a QMS and Project management of substantial systems projects such as LIMS implementation, QC documentation generation and archiving.
Your Background: You will have a strong background in QC and ideally development analytical settings gained from either the Pharma and/or Biotech sector. You will hold a strong understanding and demonstrable experience of the application of GxP requirements including design and implementation of SOPs and systems for regulated environments. Experience of working with or at a test house CRO is required as is experience of preparing for, hosting and/or delivering audits and regulatory inspections. Experience of participating in or leading analytical and manufacturing investigations along with experience of working in a continuous improvement environment / implementing lean methodologies are also required as are strong project planning skills (including familiarity with MS project and typical Project Management tools). A qualification in project management or Operational Excellence/Lean Sigma practice would be advantageous.
For more information or to apply for this Senior position, please contact Jason Johal on 01438 723 500 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46019 in all correspondence.