Blackfield Associates is exclusively partnered with a leading pharmaceutical and cellular therapy organisation in London in the search for a Quality Manager - Apheresis.
This is a key quality leadership role within a newly established apheresis service, responsible for leading the Quality Management System, ensuring regulatory compliance and patient safety, and overseeing quality governance, HTA and CQC readiness, the collection environment, and third party oversight.
Other key responsibilities include:
* Leading the QMS for the apheresis unit, including document control, change control, risk management, training, deviations, CAPA, complaints, and management review.
* Ensuring readiness for HTA licensing and CQC standards through gap analysis, action plans, inspection preparation, and audit closeout.
* Acting as the HTA Person Designated for the collection facility, with responsibility for licence governance and reporting to the Designated Individual.
* Overseeing the collection environment, including critical parameters, environmental standards, chain of identity, documentation flow, and handover processes.
* Supporting training, competency, and continuous improvement through quality reporting, KPI review, incident investigation, RCA, and CAPA.
The ideal candidate will have strong knowledge of cell therapy and apheresis operations, incident investigation, RCA, and CAPA. Experience within a cellular therapy or apheresis collection facility, or within an HTA licensed establishment, would be highly desirable, along with the ability to work independently, lead cross functional teams, and bring a practical, detail focused approach to quality and compliance.
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