The role of Quality Manager & Designated Individual at an advanced surgical skills centre involves taking full responsibility for their Human Tissue Authority licence.
As part of this role, you will ensure compliance with licensable activities, third-party agreements, and governance protocols.
You will maintain and develop the Quality Management System, including SOPs, risk assessments, audits, and compliance documentation.
Maintaining traceability, storage, and use of all human tissue is crucial to ensuring adherence to HTA requirements.
You will also be responsible for leading on HTA inspections, internal audits, and staff training across all licensable activities.
* Strong experience working within HTA-regulated environments, with a clear understanding of the regulations and inspection processes.
* Proven Quality Management background, ideally within medical devices, biosciences, or healthcare.
* A relevant qualification in biological or medical sciences, or equivalent practical experience.
* Excellent communication and stakeholder engagement skills.
* High attention to detail and strong analytical problem-solving ability.