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 and bring them to patients are seeking a Director of Quality. This role will be part of the senior management team at a newly acquired site that is being repurposed to manufacture Cell & Gene therapies at a scale for Phase 3 trials and early commercialisation. There is to be significant investment in this is with an initial £55million followed by a further £110 million over the next 5 years. What makes this stand out is that there will be a vaccine for COVID manufactured here as part of the government’s response strategy.
The Role of Quality Director:
This opportunity will be part of the senior management for the site with the responsibility to develop the strategic direction for the site to be executed through day to day responsibility for Quality at the site in compliance to GMP. Beginning with the development of the quality strategy, A high performing QMS, and provide leadership to this crucial area.
Key responsibilities include:
- Lead, design, and oversee all quality functions of this GMP manufacturing facility.
- Drive innovation as a member of the senior site
- Lead the implementation, management, and continuous improvement of the QMS
- Take the lead on regulatory and collaborator inspections, initially to gain initial MHRA approval
- Lead the integration of assays and process documentation onto the QMS
- Ensure the supply chain is fit for purpose
- Ensure the validation of the centre’s systems and equipment meets regulatory compliance standards.
- Provide compliance support for escalated issues and that these are dealt with appropriately
- Ensure the site is inspection ready at all times, develop and execute and audit programme
Required Skills and Expertise:
- You do not need to be a QP for the role, but it is advantageous.
- Experience in the design and validation of a GMP manufacturing facility for ATMP’s or Vaccines, or Biologics or Cell & Gene Therapies
- In depth understanding of GCP, GCLP and GLP, with prior exposure to an R&D environment
- Expertise in MHRA, HTA, and FDA regulations
- Experience of building and leading teams.
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 complement 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.