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VOLT are currently partnered with a clinical staged biotechnology company in Hertfordshire, who are looking to make a real difference in the in the Cell & Gene Space. This company are committed to transforming the lives of patients with cancer. They have the hunger and drive to ensure they are developing the next generation of novel T cell therapies.
This opportunity will allow you to work in a growing organisation, helping build a unique culture focused on growth, loyalty and long-term vision.
This role will give you the freedom Lead and build the Quality Assurance team who will support a quality focused culture within a growing Cell Therapy manufacturing team.
*You will be tasked on overseeing the training program, ensuring colleagues are prepared/trained on subjects such as inspections/audits, GMP regulations, QMS training etc.
*You are responsible for attending/representing the QA department in the UK at global company wide meetings, to provide relevant updates to ensure the company processes are being followed and a continuous improvement environment is being provided.
*In this role you will be the primary point of contact and interface for collaborators for day-to-day quality issues.
*Must be able to provide longer-term strategic planning activities. While also, reviewing short term activities and evaluating what can be improved.
*Perform internal/external audits while acting as the main point of contact for vendor qualification activities ensuring all partners are appropriately approved.
*Educated to degree level or equivalent with a pharmaceutical related or biotech related degree.
*Over 6 years quality assurance experience in a pharmaceutical, biotech, or biologics operation, or academic experience.
*Exposure to a clinical or commercial Advanced Therapy Medicinal Therapies or transferable working knowledge.
*Understand the GMP regulations in conformance with MHRA, FDA, EU and ICH standards.
*Previous technology transfer experience would be ideal.