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We are recruiting a QA Validation & Projects Manager to provide quality and validation leadership across Alliance Medical Radiopharmacy's UK operations. Reporting directly to the Head of Quality UK, this role sits at a senior level within the Quality function and has accountability for validation activities across all UK Radiopharmacy sites. You will act as a key interface between Quality Assurance, Regulatory Affairs, Operations and Quality Control, ensuring consistent standards, robust quality systems and ongoing inspection readiness across the network. The role combines strategic oversight with hands-on delivery, supporting both routine commercial operations and development and project programmes in a highly regulated GMP environment
Job Responsibility:
Providing QA and validation leadership across all UK Radiopharmacy facilities
Acting as the QA Validation lead for both commercial and IMP activities
Overseeing and harmonising validation activities across multiple sites, including deviations, change control, CAPAs, documentation and risk management
Acting as a subject matter expert for validation and advising site teams on projects and continuous improvement initiatives
Supporting MHRA and regulatory authority inspections, audits and responses, ensuring ongoing compliance commitments are met
Reviewing and approving quality and regulatory documentation, including SOPs, batch documentation and validation protocols
Providing QA input into product development, technology transfer and validation activities within sterile and radiopharmacy environments
Supporting the implementation of new electronic Document and Quality Management Systems
Contributing to Global Quality Management meetings and tracking actions to completion
Coaching and mentoring QA project teams and site stakeholders, acting as a role model for quality and compliance
Supporting the Head of Quality in embedding a strong quality culture, continuous improvement and inspection readiness across the UK network
Requirements:
A great positive attitude
Able to work in the UK without the requirement of sponsorship
Be flexible with working hours
Excellent Time Keeping
Great phone manner
Excellent Communication
A degree (or equivalent experience) in validation, quality or a related pharmaceutical discipline
A strong background in validation, ideally with 5+ years' experience in a pharmaceutical, radiopharmacy, sterile manufacturing or aseptic processing environment
Proven QA and validation experience within GMP-regulated manufacturing
Demonstrable experience supporting commercial products and IMP development
Strong working knowledge of UK and EU GMP, MHRA requirements and wider GxP compliance
Experience working across multi-site operations and implementing consistent quality standards
Experience supporting regulatory inspections, audits and authority interactions
Previous managerial or supervisory experience, with a track record of motivating and influencing teams
Excellent written and verbal communication skills with the ability to engage at all levels
Strong organisational skills, attention to detail and the ability to work proactively and independently
A collaborative, adaptable approach with the confidence to lead by example in quality and compliance