Quality and Compliance Manager

North Group is seeking an experienced Quality & Compliance Manager to take overall responsibility for the management, maintenance and continuous improvement of quality and compliance systems across our laboratory, logistics and wider business operations.

This is a senior, hands-on role responsible for ensuring that quality and compliance are embedded within the day-to-day operation of the business.

A key focus will be maintaining the medical laboratory Quality Management System in accordance with ISO 15189:2022 and UKAS requirements. The postholder will also have responsibility for maintaining and developing the other management systems and ISO certifications held by the business.

The Quality & Compliance Manager will work closely with the CEO, laboratory and clinical teams, IT, logistics and operational management and will be a principal point of contact for UKAS, certification bodies and external auditors. The Quality & Compliance Manager will ensure that NCRs and CAPAs are actively managed, audits take place as planned, documentation remains current, risks are identified and addressed, and quality and compliance performance is clearly visible to senior management.

Key responsibilities include:

• Laboratory Quality & UKAS
• ISO Management & Compliance
• Logistics & Operational Quality
• Audits, NCRs & CAPA
• QMS
• Governance & Reporting

Person Specification

Essential

• Significant experience managing quality systems within a regulated environment.
• Strong working knowledge of ISO 15189 and UKAS accreditation.
• Practical experience of UKAS assessments and maintaining laboratory accreditation.
• Experience managing ISO management systems.
• Experience of internal and external audits.
• Strong experience of NCRs, CAPAs and root-cause investigation.
• Experience of risk management, document control and management review.
• Ability to manage multiple standards and competing priorities.
• Strong analytical and problem-solving skills.
• Confidence working directly with senior management and challenging practices where required.

Desirable

Practical experience of several of the following would be particularly advantageous:

• ISO 9001
• ISO 14001
• ISO 22301
• ISO 27001
• Integrated Management Systems
• Information-security governance
• Medical laboratory quality
• Logistics or distribution quality
• Healthcare or diagnostic services
• Extension to Scope applications
• Supplier quality management
• Laboratory service implementation or relocation

Candidates do not necessarily need to have previously managed every standard held by North Group. However, strong ISO 15189/UKAS experience and demonstrable experience of managing ISO-based quality systems are essential.

Qualifications

A relevant degree or equivalent professional experience within laboratory science, quality management, healthcare, life sciences or a related discipline.

Formal qualifications in quality management, ISO standards, auditing or information security would be advantageous. IOSH/NEBOSH, ISO Lead Auditor or similar.

HCPC registration or previous Biomedical Scientist experience would be advantageous but is not essential where substantial ISO 15189 and laboratory or healthcare quality experience can be demonstrated.

As a Company we offer:

• 25 days annual leave + bank holidays
• Birthday Holiday
• Company sick pay
• Contribution towards professional memberships

Pay: £40,000.00-£55,000.00 per year

Work Location: In person