Lead QA Radiopharmacy

Job overview

An exciting opportunity has arisen for an experienced and motivated Quality Assurance professional to lead the Quality Assurance function within Liverpool University Hospitals NHS Foundation Trust's specialist Radiopharmacy service.

The Radiopharmacy Manufacturing Unit supplies radiopharmaceuticals to Nuclear Medicine departments across Liverpool and Cheshire and Merseyside and the wider North West region. The successful candidate will provide leadership for the Pharmaceutical Quality System, ensuring compliance with Good Manufacturing Practice (GMP), MHRA licensing requirements and other relevant regulatory standards.

Working closely with the Chief and Deputy Chief Radiopharmacists, the post holder will play a key role in maintaining regulatory compliance, supporting service development, leading quality improvement initiatives and ensuring the safe manufacture and release of radiopharmaceuticals. The role includes acting as a named Quality Controller on the MHRA Manufacturer's "Specials" Licence and leading quality-related matters during regulatory inspections.

This is an excellent opportunity to influence the future development of a modern NHS radiopharmacy service while working within a highly specialised multidisciplinary team committed to delivering safe, high-quality patient care.

Main duties of the job

• Lead the Radiopharmacy Quality Assurance team and provide professional leadership for quality-related activities.
• Maintain and continuously improve the Pharmaceutical Quality System in accordance with GMP and MHRA requirements.
• Act as a named Quality Controller on the MHRA Manufacturer's "Specials" Licence.
• Lead quality activities during regulatory inspections and audits.
• Oversee deviation management, CAPA, change control, validation and quality risk management processes.
• Support the release of radiopharmaceutical products for clinical use.
• Lead GMP training and competency development within the department.
• Support the introduction of new services, technologies and radiopharmaceutical products.
• Contribute to strategic planning and service development within the Radiopharmacy Unit.
• Work collaboratively with internal and external stakeholders to ensure the continued delivery of safe, effective and compliant radiopharmacy services.

Detailed job description and main responsibilities

The post holder will lead the Quality Assurance function for the Radiopharmacy Manufacturing Unit and will be responsible for ensuring compliance with Good Manufacturing Practice (GMP), MHRA licensing requirements and applicable quality standards. The post holder will act as a named Quality Controller on the MHRA Manufacturer's "Specials" Licence and will lead quality-related activities during regulatory inspections.

The role is responsible for maintaining and developing the Radiopharmacy Pharmaceutical Quality System, including oversight of standard operating procedures, quality risk management, audit programmes, validation activities, deviation investigations, corrective and preventive actions (CAPA), change control processes and continuous quality improvement initiatives. The post holder will ensure that facilities, equipment, processes and documentation remain compliant with regulatory requirements and industry best practice.

Working closely with the Chief and Deputy Chief Radiopharmacists, the post holder will contribute to the strategic development of Radiopharmacy services, support the implementation of new technologies and service developments, and provide specialist advice on quality, governance and regulatory matters. The post holder will also support the introduction and validation of new equipment, software systems and radiopharmaceutical services.

The post holder will lead and develop the Quality Assurance team, support workforce development and competency programmes, and contribute to the delivery of GMP training across the department. They will foster a culture of quality, compliance and continuous improvement and work collaboratively with colleagues across Radiopharmacy, Nuclear Medicine, Pharmacy and external organisations to ensure the continued provision of safe, effective and high-quality radiopharmacy services.

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.