Cellular Pathology Quality Manager
Reporting to: Principal Quality Manager and Director of Governance
Liaises with: Scientific and support staff, quality management teams, consultant pathologists, and other relevant departments.
Role
The Cellular Pathology Quality Manager is responsible for administering and monitoring the quality management system (QMS) within the laboratories. The role involves overseeing local quality activities to ensure compliance with accreditation and regulatory bodies such as UKAS, MHRA, and GXP.
Key Responsibilities
Quality Management & Compliance
* Maintain and continuously improve the QMS within the pathology departments.
* Implement and uphold the Quality Policy as directed.
* Ensure timely review, application, and documentation of quality processes.
* Organize and contribute to Quality Management Group (QMG) meetings and management reviews.
* Support continuous improvement initiatives across the laboratory network.
* Develop and execute an effective audit schedule, ensuring compliance with regulations.
* Manage document control systems to maintain accuracy and accessibility.
Training & Development
* Provide training to departmental staff on quality-related procedures.
* Participate in ongoing evaluation and improvement initiatives.
* Monitor laboratory performance and contribute to process harmonization.
* Ensure all staff adhere to quality and health & safety procedures.
General Duties
* Comply with quality standards, regulatory requirements, and internal policies.
* Attend meetings and engage in laboratory activities as required.
* Ensure proper use of IT systems relevant to quality management.
* Be flexible with work arrangements, including potential adjustments in location or hours.
Annual Review:
* Performance will be continuously assessed for competence, training, and development needs.
* Formal review will occur annually as part of a Training and Development Review.
Quality Standards & Compliance
* Uphold the Quality Management System, following all policies and procedures.
* Ensure compliance with ISO 15189:2022 and other relevant standards.
* Follow quality control measures and contribute to risk management strategies.
* Participate in audits and identify opportunities for efficiency improvements.
Essential Qualifications & Experience:
* Degree in Biomedical or Life Sciences.
* Experience in quality management or a related field.
* Extensive experience in pathology laboratories.
* Proven ability to lead regulatory inspections and audits.
* Strong incident investigation and root cause analysis skills.
Desirable Qualifications:
* Postgraduate degree in Biomedical Sciences.
* HCPC registration.
* Auditing qualifications.
Skills & Competencies:
* Excellent written and verbal communication skills.
* Strong interpersonal and leadership abilities.
* Proficiency in Microsoft Office and report writing.
* Highly organized with strong attention to detail.