Head of Quality Laboratories - Sweden

<p>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.</p><p>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.</p><p></p><p><strong>Quality Management System Leadership</strong></p><p>· Lead the maintenance and continuous improvement of the quality management system (QMS) across all laboratory sites.</p><p>· Develop and maintain quality policies, procedures, and work instructions aligned with ISO 15189:2022 requirements.</p><p>· Establish and monitor quality objectives that support organizational strategy and patient care goals.</p><p>· Oversee document control systems ensuring version control, accessibility, and timely review cycles.</p><p>· Manage electronic QMS platforms and ensure system validation and data integrity.</p><p>· Conduct annual management reviews and present quality performance to senior leadership.</p><p>· Develop and manage the quality department budget.</p><p></p><p><strong>Accreditation &amp; Regulatory Compliance</strong></p><p>· Serve as the primary liaison with national accreditation body and regulatory authorities.</p><p>· Maintain continuous accreditation readiness across all laboratory sites.</p><p>· Coordinate and lead accreditation assessments and regulatory inspections.</p><p>· Monitor regulatory developments and ensure timely implementation of new requirements</p><p>· Ensure compliance with EU IVDR Article 5(5) requirements for in-house manufactured IVDs, including performance studies, documentation, and surveillance.</p><p></p><p><strong>Risk Management &amp; CAPA</strong></p><p>· Implement and maintain a comprehensive risk management program in accordance with ISO 15189:2022 requirements.</p><p>· Oversee the CAPA system, ensuring timely and effective root cause analysis and corrective and preventive actions.</p><p>· Track and trend quality data to identify systemic issues and improvement opportunities.</p><p>· Report significant quality events and serious patient safety events to senior leadership and regulatory authorities as required.</p><p></p><p><strong>Audit Program Management</strong></p><p>· Design and execute a risk-based internal audit program covering all laboratory sites and QMS elements.</p><p>· Coordinate external audits (accreditation, regulatory) and ensure timely resolution of findings.</p><p>· Conduct supplier quality audits and assessments as required.</p><p>· Track audit findings and ensure closure within defined timelines.</p><p>· Report audit program effectiveness to management.</p><p></p><p><strong>Continuous Improvement</strong></p><p>· Foster a culture of continuous improvement.</p><p>· Establish and monitor Key Performance Indicators (KPIs) for quality across the laboratory network.</p><p>· Lead quality improvement projects with measurable outcomes.</p><p>· Implement customer feedback mechanisms and use insights to drive improvement.</p><p>· Identify and share best practices across laboratory sites.</p><p></p><p><strong>People Leadership &amp; Quality Culture</strong></p><p>· Build, develop, and lead a high-performing quality team.</p><p>· Develop and deliver quality training programs for laboratory staff at all levels.</p><p>· Ensure competency assessment and ongoing education for quality personnel.</p><p>· Promote a culture of quality, safety, and accountability throughout the organization.</p><p></p><p><strong>Stakeholder Engagement</strong></p><p>· Serve as the quality representative to senior leadership, providing regular updates on QMS performance.</p><p>· Collaborate with medical, scientific, and operational leaders on quality matters.</p><p>· Communicate with customers and referrers regarding quality programs and performance.</p><p>· Participate in industry associations, conferences, and working groups.</p><p>· Liaise with global or regional quality leadership to ensure alignment with global quality strategy.</p><p>· Participate to supplier qualification and ongoing monitoring.</p>