Within the Quality Management Office (QMO), the Senior Quality Officer is responsible for contributing to the planning, organization, implementation and continuous improvement of the integrated Quality Management System of LIH to ensure compliance with regulatory requirements, international standards and guidelines as well as relevant “Good / Best Practices” with the goal to receive and maintain related accreditation and certification, where strategically relevant.

KEY ACCOUNTABILITIES

Stratgic Elements:

• Support the organization in designing, implementing and maintaining the business processes under regulatory compliance-, risk-, quality & safety aspects as applicable. Relevant management systems are, non-exhaustive list: ISO 9001, 17025, 17043, 20387, 27001, 31000, 35001, 45001, GxP,…
• Contribute to the conception, execution, monitoring and improvement of quality management processes such as quality documents management, audits management, management of nonconformities, customer complains and related actions, management review and risk management.
• Promote quality achievements and performance improvement throughout the organization.

Operational Elements:

• Act as subject matter expert for nonconformity and customer complaints management: consult and train staff in the process; monitor process execution for compliance with internal rules.
• Act as operational system administrator backup for the quality documents management system; perform quality review of documents and participate in their publication.
• Take leadership, under supervison of the Head of QMO, for the quality audits management process.
• Be responsible for quality-related regulatory watch.
• Particpate in risk assesments, their documentation and follow-up; promote risk-based thinking within the LIH.
• Participate in the conception, coordination and provision of (internal) training.
• Participate in or lead (improvement) projects.
• Maintain internal tools for process monitoring (KPIs).

KEY SKILLS, EXPERIENCE AND QUALIFICATIONS

• Master’s degree in an applied science (Biology, Chemistry…); a PhD would be an asset
• Experience in working in a laboratory or a regulated environment; experience in a quality-related function in a laboratory or research institute context.
• Experience in the application of quality norms (at least ISO 9001, ISO 17025, ISO 27001, 31000).
• Knowledge of quality tools, e.g. risk management, process analysis, lean management
• Detail oriented / Ability to understand and analyse data for evidence-based decision making.
• Good interpersonal, communications and colla-boration skills, e.g. being able to listen and find compromises.
• Open-minded, diplomatic, self-reliant, decisive, tenacious and ethical
• Good writing skills and presentation skills
• Must be proficient in the use of computers and general office software.
• Must speak and write English fluently. Additional fluency in French would be preferred.

Desirable

• Experience in the implementation and maintenance of an integrated QMS in a lab/research institute environment.

Please refer the Job description for details