About us
Founder & Principal Consultant
Mylène is the founder and Principal Consultant of MF Life Sciences GxP Consulting GmbH, Basel, Switzerland since 2019.
Mylène has been working in the field of Quality Management and validation for Pharmaceutical, Biotech, Medical Devices industries for the last 20 years in Switzerland, and in several countries in Europe and North America.
She is a chemical engineer and holds a master’s degree from the Université de Sherbrooke, Canada as well as a degree in Quality Assurance Management degree from L’École de Technologie Supérieure, Université du Québec.
Prior founding her consulting company, Mylène worked as a Head of Quality for Biotech start-up companies in the field of biological products such as monoclonal antibodies. She has acquired a large hands-on GxP experience in implementing & maintaining GxP quality systems & quality organization to support fast-paced drug approval to market.
She spent more than 20 years leading QA functions in the Life Sciences industry. She worked for 10 years as a Region Head Quality Country Organization Europe at Novartis and implemented global electronic quality systems at Merck Serono. Mylène contributed to the creation of several GxP quality systems & organization and implemented QA oversight programs of CMOs & CROs as well as supporting the approval of new biological drug (BLA).
Since 2019, she is supporting the Life Sciences industry as a consultant in building/managing GxP quality organization/quality systems and preparing/training/leading FDA & EMA & Swissmedic GxP Inspections readiness covering pre-clinical and clinical trials phase 1, 2, 3 up to commercialization.
She shares a passion for quality & compliance, innovation, business continuous improvements, training and developing GxP QA teams.
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