Head of Quality Laboratories - Sweden

About the role

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. - 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

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