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Quality manager, apheresis clinic

London
Quality manager
Posted: 18 February
Offer description

We are seeking a Quality Manager who will be responsible for providing leadership and subject matter expertise to the Apheresis Clinic, to ensure that the facility operates to the highest standards of quality governance, regulatory compliance, and patient safety. The role leads the Quality Management System (QMS) for apheresis, drives continuous improvement, and ensures alignment with HTA licensing requirements, CQC accreditation standards, local policies, and applicable GxP/GMP expectations across the end-to-end cellular therapy pathway. This is a fantastic opportunity for an enthusiastic, driven and experienced Quality Manager wanting to join an established organisation. ​ Company Information Advent Bioservices is an HTA licenced Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services, currently establishing a satellite apheresis clinic in London. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using highly personalised therapies. ​ Job Summary Based in London, the purpose of this role is to lead the quality management system and governance of an apheresis clinic in London. The successful candidate will work within a fast-paced multidisciplinary HTA/ GxP / GMP environment ensuring all documentation and information is processed in line with these requirements. ​ You will have the following experience/qualifications Must have knowledge of clinical aspects of cell therapies and apheresis operations Must have experience of incident investigation, root cause analysis and CAPA management ​ Must have direct experience in cellular therapy/apheresis collection facilities and/or working within an HTA licensed establishment. Must have strong organisational skills and ability to prioritise, work under pressure Must have excellent attention to detail Line management experience would be advantageous ​ Travel between Advent’s London and Sawston sites may be required. ​ We are not accepting agency applications for this role

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