As a company they are the driving force behind the Cell & Gene Therapy sector in the UK with the expertise, facilities, and science to commercialise these advanced and life changing therapies. With projects across a range of therapeutics areas with these coming from the UK, EU, US and Asia. They take an innovative approach to develop and adopt the latest technologies to keep them are the forefront of the sector.
The QA Specialist is a senior role within the team where you will be responsible for a mixture of hands on duties, leadership, and strategic input into development and evolution of their quality management systems. Alongside the day to day QA Activities you will have the responsibility for taking the lead on additional special projects in line with their continued expansion.
- Core purpose is to ensure compliance to GMP by ensuring the QMS is fit for purpose
- Strategic responsibilities for the tactical design & implementation processes to ensure compliance is maintained. Working with senior colleagues.
- Be the SME from a QA perspective for the facility and operations
- Key point of contact of collaborators and their respective projects
- Lead day to day operations such as internal audit programmes, investigations and CAPA’s
- Ensure QMS development keeps pace with site development
- Lead Continuous improvement initiatives
- Manage suitability of QMS through regular review with senior colleagues
Desired Skills and Experience:
- You will need to have experience of quality assurance in a GMP regulated sterile manufacturing environment within the Biologics, ATMP, cell / gene therapy or similar sectors.
- Strong all round QA experience.
- Prior experience in dealing with regulatory bodies and / or clients is an advantage but not essential.
- You will need to have experience of managing quality management systems along to GMP to ensure they are fit for purpose and experience design of governance processes.
- Experience of working with external stakeholders and managing relationships
The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialization of these fast developing, cutting edge technologies. They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services. This currently consists of 12 (of which 6 very recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.