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Quality 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.

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