Head of Quality Management

The Luxembourg Institute of Health (LIH) is a leading biomedical research organization dedicated to improving health outcomes through cutting-edge scientific research. To strengthen our Quality Management Office, we are looking for an experienced and inspiring Head of Quality Management to lead the development and continuous improvement of our integrated Quality Management System across the institute.

Your Role
As Head of Quality Management, you will define, implement, and continuously improve LIH's integrated Quality Management System (iQMS), ensuring that it supports the institute's strategic ambitions while meeting the highest international quality, regulatory, and operational standards.
Reporting to the Deputy CEO, you will lead the Quality Management Office and work closely with managers across the organization to foster a culture of quality, continuous improvement, operational excellence, and risk-based thinking.
This role offers the opportunity to shape quality strategy at the institutional level while contributing directly to the performance and sustainability of a leading biomedical research institute.

Your responsibilities
As Head of Quality Management, you will:

• Define, together with the CEO and Executive Committee, the long-term strategy, policies, and objectives of the integrated Quality Management System.
• Lead, coach, and develop the Quality Management Office team.
• Ensure the implementation, maintenance, and continuous improvement of the institute's integrated management system covering quality, risk management, information security, and operational excellence.
• Ensure compliance with applicable international standards, including ISO 9001, ISO 27001, ISO 17025, ISO 20387, ISO 17034, ISO 17043, GxP requirements, and recognized biobanking best practices.
• Coordinate and support accreditation and certification activities and maintain regulatory compliance.
• Act as process owner for key quality processes, including document control, CAPA management, non-conformities, customer complaints, and internal auditing.
• Plan, coordinate, and oversee internal and external audits, ensuring effective follow-up of findings and continuous improvement actions.
• Support Executive Management through performance monitoring, quality reporting, KPI development, and Management Reviews.
• Promote a quality, safety, and risk-aware culture across the institute through coaching, communication, and training initiatives.
• Collaborate closely with the Data Protection Officer and Information Security Officer to integrate data protection and information security requirements into business processes.
• Identify and implement digitalisation and AI-enabled opportunities to improve quality assurance, quality control, compliance, and continuous improvement.
• Drive cross-functional process improvement initiatives that enhance operational efficiency beyond compliance requirements.
• Monitor regulatory developments and advise management on emerging risks and organizational changes.

Your profile

You hold a Master's degree in Biology, Chemistry, Life Sciences, or another relevant scientific discipline.
You also bring:

• Significant experience working in a laboratory, biomedical research, diagnostics, or another regulated life sciences environment.
• Solid experience in Quality Management Systems.
• Demonstrated experience implementing and maintaining international quality standards such as ISO 9001, ISO 17025, GxP, or equivalent.
• Proven experience managing audits and interacting with certification and accreditation bodies.
• Previous experience leading and developing teams.
• Excellent analytical, organizational, and problem-solving skills.
• Strong communication and stakeholder management abilities.
• The ability to influence, coach, and drive change across multidisciplinary teams.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
• Excellent command of English, both written and spoken.

The following would be considered strong assets:

• Knowledge of equipment qualification and software validation.
• Knowledge of metrology principles under ISO 17025.
• Change management expertise.
• Fluency in French and/or German.