Job Description

Lead with integrity, certify with precision -- shape the future of radiopharmaceutical quality across the UK.
R&D Partners is seeking an experienced and driven Country Quality Lead & Qualified Person (QP) to join a leading pharmaceutical organization in UK. This critical leadership role involves ensuring compliance with UK and EU GMP regulations, overseeing site-level quality assurance and control activities, and providing QP certification and batch release of radiopharmaceuticals. The ideal candidate will partner closely with operations, regulatory, and corporate teams to maintain the highest standards of quality, safety, and compliance across UK operations.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:

• Ensure all operational activities across UK sites comply with current Good Manufacturing Practices (cGMP), legal and regulatory requirements, and the corporate quality management system.

• Establish and maintain a robust quality organization within the UK to support compliance and operational excellence.

• Oversee quality programs, documentation, reporting, incident management, and escalation processes to ensure timely and GMP-compliant decision-making.

• Lead inspection readiness efforts and ensure successful outcomes of Health Authority inspections across all UK sites.

• Provide strategic and technical leadership for quality operations across all UK sites.

• Conduct annual audits of UK manufacturing sites to verify adherence to national and corporate quality standards.

• Monitor and evaluate site quality performance using defined Key Quality Indicators (KQIs) to drive continuous improvement.

• Support drafting and revising Quality Agreements with Contract Givers/Acceptors in collaboration with the Corporate Quality Department.

• Actively participate in inspections by regulatory authorities (e.g., MHRA) and external auditors, including follow-up and remediation activities.

• Oversee supplier qualification activities, including audits and ongoing compliance monitoring.

• Lead customer complaint investigations in coordination with the Corporate Quality Department.

• Escalate significant Quality/cGMP issues to the International Quality Head and relevant stakeholders.

• Conduct Quality Assessments across national sites, ensuring timely cGMP-compliant decision-making and follow-up.

• Drive corrective and preventive actions based on QA performance reports.

• Contribute to recruitment, training, and development of Quality personnel across UK sites.

Key Skills and Requirements:

• Minimum of 5 years of experience in a managerial role within a pharmaceutical Quality Department.

• Demonstrated leadership capabilities with the ability to guide and develop quality teams.

• Strong organizational skills, including time management, risk management, and prioritization.

• In-depth knowledge of GMP and ISO quality systems and standards.

• Solid understanding of national and international regulatory requirements relevant to radiopharmaceutical manufacturing.

• Excellent communication skills to collaborate effectively across departments and with external partners.

For more information, please contact Frankie Cunningham.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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Skills Required