The National Head of Quality Laboratories is a senior leadership role responsible for developing, implementing, and maintaining a robust Quality Management System (QMS) across our network of clinical laboratories. This role ensures compliance with ISO 15189:2022, EU IVDR (including Article 5(5) for in-house IVDs), and all applicable national regulatory requirements.
The National Head of Quality Laboratories will drive a culture of quality excellence, continuous improvement, and patient safety while serving as the primary quality representative to accreditation bodies, regulatory authorities, and key stakeholders.
Quality Management System Leadership
- Lead the maintenance and continuous improvement of the quality management system (QMS) across all laboratory sites.
- Develop and maintain quality policies, procedures, and work instructions aligned with ISO 15189:2022 requirements.
- Establish and monitor quality objectives that support organizational strategy and patient care goals.
- Oversee document control systems ensuring version control, accessibility, and timely review cycles.
- Manage electronic QMS platforms and ensure system validation and data integrity.
- Conduct annual management reviews and present quality performance to senior leadership.
- Develop and manage the quality department budget.
Accreditation & Regulatory Compliance
- Serve as the primary liaison with national accreditation body and regulatory authorities.
- Maintain continuous accreditation readiness across all laboratory sites.
- Coordinate and lead accreditation assessments and regulatory inspections.
- Monitor regulatory developments and ensure timely implementation of new requirements
- Ensure compliance with EU IVDR Article 5(5) requirements for in-house manufactured IVDs, including performance studies, documentation, and surveillance.
Risk Management & CAPA
- Implement and maintain a comprehensive risk management program in accordance with ISO 15189:2022 requirements.
- Oversee the CAPA system, ensuring timely and effective root cause analysis and corrective and preventive actions.
- Track and trend quality data to identify systemic issues and improvement opportunities.
- Report significant quality events and serious patient safety events to senior leadership and regulatory authorities as required.
Audit Program Management
- Design and execute a risk-based internal audit program covering all laboratory sites and QMS elements.
- Coordinate external audits (accreditation, regulatory) and ensure timely resolution of findings.
- Conduct supplier quality audits and assessments as required.
- Track audit findings and ensure closure within defined timelines.
- Report audit program effectiveness to management.
Continuous Improvement
- Foster a culture of continuous improvement.
- Establish and monitor Key Performance Indicators (KPIs) for quality across the laboratory network.
- Lead quality improvement projects with measurable outcomes.
- Implement customer feedback mechanisms and use insights to drive improvement.
- Identify and share best practices across laboratory sites.
People Leadership & Quality Culture
- Build, develop, and lead a high-performing quality team.
- Develop and deliver quality training programs for laboratory staff at all levels.
- Ensure competency assessment and ongoing education for quality personnel.
- Promote a culture of quality, safety, and accountability throughout the organization.
Stakeholder Engagement
- Serve as the quality representative to senior leadership, providing regular updates on QMS performance.
- Collaborate with medical, scientific, and operational leaders on quality matters.
- Communicate with customers and referrers regarding quality programs and performance.
- Participate in industry associations, conferences, and working groups.
- Liaise with global or regional quality leadership to ensure alignment with global quality strategy.
- Participate to supplier qualification and ongoing monitoring.
Requirements
Excellent interpersonal, organizational & communication skills with excellent attention to detail.- Works effectively across functions and sites; builds strong relationships with stakeholders.
- Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
- Responsive problem solver and action oriented.
- Makes sound decisions based on data, risk assessment, and regulatory requirements.
- Ability to affect change.
- Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions.
- Demonstrates ethical behavior and upholds quality principles without compromise.
Education and Experience
- Bachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment.
- Minimum 8-10 years in quality management within a clinical laboratory, diagnostics, or healthcare environment.
- Minimum 5 years in a quality leadership role, managing teams and influencing across multiple sites.
- Demonstrated experience leading ISO 15189 accreditation processes.
- English fluent as a must (presenting, writing, reading).
- Minimum Years Recommended and/or Preferred: 8-10 years
