Head of Quality Laboratories - Sweden

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.