QA Manager and Responsible Person RP - Smart4Sciences : Job Details

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