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Volt Europe Limited
,
Stevenage, Hertfordshire
Quality Assurance Director/Associate Director
Overview
I am actively looking for a Quality Assurance Director/Associate Director in Stevenage. Please see below. 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. Responsibilities 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. Requirements 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.