Sylvain LEFEBVRE

Championed the global remediation and alignment of Quality Systems, driving ISO 13485, resulting in improved audit outcomes and sustainable regulatory readiness. Redesigned and optimized Quality Management Systems (QMS) to meet ISO 9001 and ISO 13485 standards, strengthening traceability, documentation integrity, and inspection preparedness. Led cross-functional collaboration with Regulatory, Engineering, and Operations to streamline validation, CAPA, and risk-management processes, reducing non-conformities and enhancing overall product quality. Developed and delivered comprehensive training programs for QA and manufacturing teams on GMP, GDP, and data integrity principles, fostering a proactive culture of compliance and continuous improvement. Provided strategic leadership during executive transition, ensuring uninterrupted regulatory oversight, stakeholder alignment, and successful continuation of key quality initiatives supporting global market growth.