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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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