Quality Assurance Manager

Location: Hospital-based site

Reporting to: Principal Quality Manager

Accountable to: Director of Governance & Site Lead

Overall, Purpose of the Role: To lead and support the administration, monitoring, and implementation of the Quality Management System (QMS) across the laboratory site. This role ensures that quality and compliance activities meet the standards required by regulatory and accreditation bodies (e.g., UKAS, CQC, MHRA, GxP) and supports continuous improvement across all related facilities.

Key Responsibilities:

• Maintain and continually improve the QMS across the pathology departments.
• Review and manage quality documentation and processes in a timely manner.
• Organise and contribute to Quality Management Group (QMG) meetings.
• Support the planning and execution of routine Management Reviews across the group.
• Support continuous improvement initiatives across the laboratory network.
• Develop and manage a comprehensive internal audit schedule, including preparation and review of the Quality Manual.
• Oversee document control systems ensuring compliance and accuracy.
• Respond to incidents, investigations, complaints, and enquiries, preparing thorough reports as required.
• Support staff training and development in quality-related activities.
• Promote harmonisation of quality and operational processes across departments and sites.
• Ensure all quality-related procedures comply with Health and Safety standards.
• Provide support to other laboratories within the network as needed.
• Monitor compliance to identify and escalate risks where necessary.

General Duties:

• Understand the structure and responsibilities of the department and contribute to its daily operations.
• Perform assigned duties in compliance with accreditation standards, regulations, and internal quality systems.
• Communicate professionally and confidentially with staff and external stakeholders.
• Adhere to departmental policies, especially in relation to Health and Safety and Fire procedures.
• Promote and embody organisational values and maintain high professional standards.
• Undertake additional responsibilities as directed by senior management.
• Participate in annual performance reviews and development discussions.

Person Specification

Qualifications:

• Degree or Postgraduate degree in Biomedical or Life Sciences – Essential (E)
• Qualification in Quality Management or equivalent relevant experience – Essential (E)
• HCPC registration or equivalent professional body – Desirable (D)

Experience:

• Significant experience in quality management within a laboratory environment – Essential (E)
• Experience leading regulatory or accreditation inspections – Essential (E)
• Strong background in incident handling, including root cause analysis and CAPA – Essential (E)
• Auditing qualification or substantial hands-on audit experience – Essential (E)
• Proven ability in professional report writing – Essential (E)
• Experience working as a Biomedical Scientist in a Blood Sciences laboratory – Desirable (D)

Skills and Abilities:

• Excellent written and verbal communication skills – Essential (E)
• Strong interpersonal and teamwork abilities – Essential (E)
• Ability to work independently and take initiative – Essential (E)
• High level of proficiency with Microsoft Office applications – Essential (E)
• Exceptional attention to detail and accuracy – Essential (E)
• Well-developed organisational and record-keeping skills – Essential (E)
• Self-motivated, with strong leadership qualities – Essential (E)
• Ability to interpret standards, align expectations, and drive outcomes – Essential (E)
• Committed to meeting deadlines and delivering results – Essential (E)
• Flexible and adaptable approach to working hours and changing priorities – Essential (E)