A pioneering company who are at the centre of the Cell & Gene Therapy sector who provide the expertise needed to commercialise these life changing therapies. Are seeking a Senior Quality Assurance Specialist to join their growing team at their market leading and unique manufacturing facility based in Stevenage. Please note this role requires weekend working on a rotational basis.
The company’s mission is to drive its growth of the sector to ensure these therapies are commericalised and have an international presence with projects coming from Europe, US and Asia. To complement their projects coming from innovative UK projects. They collaborate with academia & industry, providing their expertise to take therapies across the translational gap, into the clinic and the through clinical trials. Taking an innovative approach to develop and adopt the latest technologies to keep them are the forefront of the sector.
The Role of Senior Quality Assurance Specialist:
This opportunity will be to apply leadership within the team with the responsibility for the development and maintenance of the Quality Management Systems at the manufacturing facility. This is an influential role where you will be involved in the process mapping and the development of processes for the management of key quality and business processes. Added to this you will be a primary point of contact for assigned Collaborators for all matters relating to quality, with the responsibility for managing interactions and the relationship.
- Take a key role in the development, implementation, and establishment of processes to ensure compliance of their manufacturing operations to GMP.
- Operate as a key point of contact for collaborator / collaborators
- Lead continuous improvement projects
- Participate in the preparation of regulatory audits, and execution of internal audits
- Ensure the QMS is maintained and fit for purpose – including its evolution and continuous improvement
- Operate as a Quality SME for facility operations
- Escalate issues when appropriate, identifying the correct pathways
- Review and improve QMS on regular basis
Please note this opportunity requires weekend working on a rotational basis.
Required Skills and Expertise:
- You will need to be educated to at least Degree level
- Experience in the building and implementation of GMP processes
- Experience of GMP regulated sterile manufacturing operations e.g. Biologics or ATMP’s
- Prior exposure of interacting with regulatory agencies – desirable
- Experience of interacting with collaborators / clients – desirable
The company’s aim is to advance the cell & gene therapy sector to make the UK the place to commercialise these life changing therapies. They have the capabilities to take a therapy from the discovery phases, across the translational gap to the clinic and then through clinical trials to launch. Using their R&D expertise to achieve this along with their drive for innovation and continuously adopting the latest and most effective approaches. To completment their R&D efforts they have world class clinical operations, regulatory, health economics and market access expertise. Added to this they have developed a unique and highly successful GMP manufacturing facility based in Stevenage where collaborators can manufacture their therapies for clinical trial and commercial use.
They have a strong culture that is focused on collaborative and innovative working to deliver these life changing therapies to patients. As a company they offer excellent career development opportunities through their L&D programme that not only gives you the skills to advance your career but creates opportunities to take the step forwards to utilise them in a new position. Added to this they are continuing to expand as the demand for their expertise increases and they explore new areas of the sector.