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Skills Alliance Limited
,
London, Greater London
Quality Assurance Director (GMP) - Innovative biotech
Overview
Skills Alliance has been exclusively retained by a pioneering, early-stage biotechnology company to hire a Quality Assurance Director. Focused on developing the first-of-its-kind immunotherapies for cancer and other serious diseases, our client is looking to commence their first cell therapy trials in both solid tumor and hematological malignancies. The QA Director is a highly visible and influential position with oversight of GMP-related activities, and responsibility for the development of the Quality system. The role reports to the Executive Quality Head and is office-based in Greater London. Key Accountabilities: Maintain relevant industry knowledge affecting Quality processes Ensure management of company policies and the quality management system (QMS) Responsible for GMP, GCLP, GDP, HCP, FDA compliance and other associated cell and gene therapy regulatory/ ISO requirements Lead audits, internal and external Review and input into Quality Technical Agreements, validation protocols and reports Provide Quality support for process development associated with product manufacturing Manage controlled documents, SOPs, training and batch manufacturing records Oversee and coordinate corrective and preventative action plans, product complaints and out of specification reporting Demonstratable experience in authoring and management of controlled documents such as SOPs, Batch Manufacturing Records, Product Specification Files etc. Education & Qualifications: BSc in a life science or equivalent discipline, advanced degree preferred Experience within a pharmaceutical or biotech company Experience with Quality Assurance experience with ATMP products preferred Experience in developing and implementing a QMS GMP knowledge, specifically ISO-14644 or clean room experience Expertise in GxP regulations preferred; GMP experience mandatory Experience leading audits and pre-license inspection activities. This is an opportunity to join an innovative biotech and work in a dynamic, start-up environment. The company seeks engaging and scientifically driven individuals. Skills Alliance is exclusively partnered with this innovative company. Please click APPLY or call Karina Sharipova at 44 (0) 207 220 6205 to receive further information, including a full job description.