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Join a leading logistics partner to the healthcare and pharmaceutical industry, as a Quality Manager & Responsible Person (RP). This is a crucial leadership role, responsible for site-level Quality operations, ensuring full compliance with GDP, MHRA, ISO, and internal quality systems.
Key Responsibilities
- Lead and manage the on-site Quality department, overseeing personnel, operations, and performance.
- Act as the named Responsible Person for MHRA licences, ensuring adherence to GDP (2013/C 343/01).
- Ensure robust implementation of the Quality Management System including deviations, CAPAs, change control, and self-inspections.
- Maintain compliance with GxP, ISO 9001, ISO 13485, and regulatory standards.
- Conduct internal and external training on key QA topics and regulatory requirements.
- Oversee supplier management, quality risk assessments, validation processes, and complaint handling.
- Lead audit readiness and host MHRA, ISO, and client audits, ensuring timely resolution of any findings.
- Act as a key quality liaison for clients, attending meetings and maintaining strong working relationships.
- Prepare, review, and approve Technical and Quality Agreements.
- Ensure traceability of recalls and release of returned and quarantined stock in accordance with MHRA guidelines.
About You
- Extensive experience in pharmaceutical or medical device quality assurance, preferably in a logistics/distribution setting.
- Eligible to act as Responsible Person (RP) under MHRA WDA(H) and WQP guidelines.
- Solid understanding of Good Distribution Practice (GDP) and the Falsified Medicines Directive.
- Working knowledge of environmental monitoring, computer systems validation, and ISO standards.
- Strong leadership, mentoring, and coaching skills - able to manage and motivate cross-functional teams.
- Excellent communication and stakeholder management capabilities.
- Proficient in Microsoft Office and quality systems; Lead Auditor certification is desirable.
- Willing to travel nationally and occasionally within Europe.
What's on Offer
- Full benefits package including healthcare and pension.
- Opportunities to grow within a respected, international organisation.
- Collaborative and values-driven work culture.
Apply now to join a high-impact team where your expertise ensures the safe, compliant delivery of life-saving products or contact Gareth Gooley at Smart4 Sciences on
