QA Manager
Reference: rk_AM102026-87787_1792578816
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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