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Genesiscancercareuk logo

Cellular Therapies Quality Lead

Genesiscancercareuk
Posted 3 weeks ago
🇬🇧United Kingdom🏢Hybrid📁Engineering & Development
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Are you an experienced cellular therapies quality professional with a proven track record of establishing a JACIE accredited service? GenesisCare UK is seeking an expert Cellular Therapies Quality Lead to provide national leadership for the quality management and regulatory governance of our expanding cellular therapies programme. This is a newly created national role, offering the opportunity to lead the development, implementation and continuous improvement of the quality framework that underpins our cellular therapies services. We are looking for an individual who has successfully established and delivered a JACIE accredited service and can bring that expertise to GenesisCare as we continue to develop this exciting area of care. Working remotely with regular travel across our UK network (typically 1–2 days per week), you will work in partnership with multidisciplinary clinical, operational and laboratory teams to ensure our services meet the highest standards of quality, governance and regulatory compliance. This is a strategic leadership position suited to an established specialist who can confidently lead accreditation programmes, influence stakeholders at all levels and drive continuous improvement across the entire cellular therapies pathway. What You'll Do Lead the development, implementation and ongoing management of the Cellular Therapies Quality Management System (QMS). Provide expert leadership to establish and maintain JACIE accreditation across GenesisCare's cellular therapies services. Lead organisational readiness for JACIE inspections, coordinating preparation, evidence gathering, staff engagement and post-inspection action plans. Ensure compliance with JACIE, HTA, CQC and all relevant regulatory and professional standards. Oversee document control processes, ensuring robust governance, version control and regulatory compliance. Develop and deliver a comprehensive internal audit programme, driving continuous quality improvement. Lead governance across the cellular therapies pathway, including incident management, risk management, CAPA and performance monitoring. Provide expert advice and guidance on regulatory requirements, accreditation standards and quality best practice. Develop and oversee training and competency frameworks to ensure compliance with quality standards. Analyse quality metrics and present meaningful reports to senior stakeholders to support assurance and strategic decision making. Work collaboratively with clinical, operational and laboratory teams to embed a culture of quality, patient safety and continuous improvement. Home-based and national roles require travel to support business needs. The postholder must hold a full, valid UK driving licence and have access to their own vehicle. The vehicle must be appropriately maintained, roadworthy, and insured for business use in line with company policy. What You'll Have Essential Demonstrable experience leading the establishment and successful achievement of JACIE accreditation for a cellular therapies service. Significant experience leading quality management within cellular therapies, stem cell transplantation, haematology or an equivalent highly regulated healthcare environment. Extensive knowledge of JACIE standards and their practical implementation. Strong understanding of HTA, CQC and other relevant regulatory frameworks. Experience leading regulatory inspections and accreditation programmes. Proven experience designing, implementing and maintaining Quality Management Systems. Experience delivering internal audit programmes and driving quality improvement initiatives. Excellent knowledge of clinical governance, risk management, incident investigation and CAPA processes. Excellent stakeholder management, leadership and influencing skills, with the ability to work effectively across multidisciplinary teams. Degree in a scientific, clinical or quality-related discipline (or equivalent experience). Desirable Postgraduate qualification in Quality Management, Regulatory Affairs or a related discipline. Experience establishing new cellular therapies services. Project management qualification or equivalent experience. Why Choose GenesisCare Discover what's in store for you when you join the GenesisCare UK team: Shape your work-life balance with 26 days of annual leave, plus bank holidays, and the option to buy more or sell back annual leave. Prioritise your wellbeing with complimentary private medical and dental cover, access to our Employee Assistance Programme and Income Protection. Access world-class radiotherapy treatment for you and your immediate family, if required. Secure your future with a competitive Company Contributory Pension Scheme. Support your wellbeing through our wellbeing community, with access to Babylon Health and Headspace. Free parking at most of our centres. Exclusive retail discounts. Who We Are GenesisCare UK is the leading provider of private oncology services in the UK, pioneering a transformation in cancer care through innovative, personalised treatments that improve patients' quality of life and outcomes. We take an integrated approach to cancer care, treating the whole patient through personalised treatment programmes that combine world-class clinical care with wellbeing support and exercise medicine. Working alongside leading clinicians, universities and research partners, we continue to expand access to innovative therapies and clinical trials, helping shape the future of cancer treatment. Join GenesisCare and play a leading role in establishing the quality foundations that will support the future of cellular therapies across our UK network.

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