Full job descriptionQuality Assurance Manager - UK - Onsite


Working within the unique and highly regulated radiopharmaceutical industry, this role offers the opportunity to make a genuine impact on products that support vital diagnostic and treatment pathways. As Quality Assurance Manager, you’ll lead site quality activities, oversee GMP compliance, and help drive a culture of quality excellence within a specialist manufacturing environment.


Key Responsibilities:
*Act as the site Quality Assurance lead, providing quality oversight across manufacturing, testing, and operational activities.
*Lead and develop the QA team, managing performance, training, workload planning, and staff development initiatives.
*Ensure the site Quality Management System remains compliant with GMP requirements and industry best practices.
*Review and approve quality events including deviations, CAPAs, change controls, complaints, OOS and OOT investigations.
*Drive continuous improvement initiatives and support the implementation and enhancement of eQMS and LIMS platforms.
*Lead internal audit programmes and support supplier, contractor, client, and regulatory inspections.
*Maintain oversight of data integrity practices and ensure appropriate controls and assessments are implemented.
*Review and approve quality documentation including SOPs, risk assessments, validation documentation, and site quality records.
*Support product introductions, validation activities, and cross-functional projects from a QA perspective.
*Lead site inspection readiness activities and act as a key contact during MHRA and customer audits.
*Monitor regulatory developments and ensure quality systems remain aligned with evolving GMP requirements.
*Work closely with operational teams to ensure effective contamination control strategies and ongoing compliance across the site.
*Support quality defect investigations, recalls, and escalation of critical quality issues where required.
*Promote a strong quality culture through coaching, mentoring, and training across the wider business.


Requirements:
*Degree in a scientific discipline or equivalent pharmaceutical industry experience.
*Minimum of 5 years’ Quality Assurance experience within a GMP-regulated pharmaceutical environment.
*Previous leadership, supervisory, or people management experience as well as experience in an aseptic/sterile environment is imperative.
*Strong working knowledge of GMP, quality systems, and regulatory compliance requirements.
*Experience managing deviations, CAPAs, change controls, audits, and validation activities.
*Excellent communication and stakeholder management skills.
*Strong organisational skills with a proactive approach to problem solving and continuous improvement.
*Experience supporting regulatory inspections and customer audits.
*Proficiency in Microsoft Office applications and electronic quality management systems.