Lead QA Radiopharmacy

Liverpool University Hospitals NHS Foundation Trust; Liverpool; On-site; GBP 60,000 - 90,000; Full time

Job summary

Liverpool University Hospitals NHS Foundation Trust is seeking an experienced Quality Assurance professional to lead the Radiopharmacy QA function. The post holder will ensure GMP compliance, MHRA licensing standards and oversee the Pharmaceutical Quality System within the Radiopharmacy Unit, including oversight of SOPs, CAPA and change control.

Collaboration with Chief Radiopharmacists and external partners will be essential to deliver safe, high-quality radiopharmacy services.

Qualifications

• Experience leading the QA function in a radiopharmacy or GMP-regulated setting.
• Deep knowledge of GMP and MHRA licensing requirements.
• Proven ability to lead regulatory inspections and audits.

Responsibilities

• Lead the Radiopharmacy Quality Assurance team and provide professional leadership.
• Maintain and improve the Pharmaceutical Quality System in line with GMP and MHRA.
• Act as the named Quality Controller on the MHRA 'Specials' Licence.
• Lead quality activities during regulatory inspections and audits.
• Oversee deviation management, CAPA, change control, validation and quality risk management.
• Support release of radiopharmaceutical products for clinical use.
• Lead GMP training and competency development.
• Contribute to strategic planning and service development within Radiopharmacy.
• Collaborate with stakeholders to ensure safe, compliant radiopharmacy services.

Skills

QA Leadership

Regulatory Compliance

GMP MHRA Knowledge

MHRA Licensing

Quality System Management

Job description

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.

• 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.

Liverpool University Hospitals NHS Foundation Trust comprises Aintree University Hospital, Broadgreen Hospital & Royal Liverpool University Hospital. We are part of NHS University Hospitals of Liverpool Group, formed on 1 Nov 2024 from the coming together of LUHFT and Liverpool Women's NHS Foundation Trust. The Group was born from a shared aim to improve the care we provide our patients., 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.
UHLG is one of the largest employers in the region, with over 16,800 colleagues dedicated to caring for our communities - from birth and beyond. For the 630,000 people across Merseyside, we are their local NHS. We provide general and emergency hospital care, alongside highly specialised regional services for more than two million people in the North West. Aintree University Hospital is the single receiving site for adult major trauma patients in Cheshire and Merseyside and hosts a number of regional services including an award-winning stroke facility. Broadgreen Hospital is home to elective surgical, diagnostic and treatment services, together with specialist patient rehabilitation. Liverpool Women's Hospital specialises in the health of women and babies, delivering over 7,200 babies in the UK's largest single site maternity hospital each year. The Royal Liverpool University Hospital is the largest hospital in the country to provide inpatients with 100% single bedrooms and focuses on complex planned care and specialist services.