Mélanie Lamer
Head, Regulatory Affairs and Quality Assurance
“You are always a student, never a master. You have to keep moving forward.”
– Conrad Hall
Mélanie studied at the University of Quebec at Montréal (UQAM), where she earned a bachelor’s degree in biology. Having started her career as a validation specialist consultant, she quickly developed expertise in the qualification and validation of equipment, systems, facilities, and manufacturing and packaging processes. This experience enabled her to master essential concepts related to a drug’s lifecycle, from process design to commercial production, and to apply principles of risk management associated with quality. Furthermore, consulting allowed her to travel the world and apply various regulations based on each country’s specific standards. In addition to her technical expertise, her ongoing training in project management enabled her to provide clients with turnkey experience. This background gives her a unique perspective on drug development, from process design all the way to the patient. Following her activities in validation, she added Quality Assurance to her fields of expertise.
Building on this momentum, she joined Servier Canada in 2010 as Quality Assurance Manager. This experience enabled her to further develop the concept of risk management related to the quality of a drug by adopting a holistic view of drug development, applying more policies, regulations, and guidelines, and interacting with multiple stakeholders, including Health Canada. She has successfully led numerous audits and regulatory inspections. In 2017, she was promoted to the position of Quality Assurance Senior Manager.
Since 2024, she has been Head, Regulatory Affairs and Quality Assurance. In addition to quality assurance activities, this role involves overseeing, planning, and strategically implementing regulatory activities to ensure the efficacy, safety, and quality of drugs in clinical studies and on the market. In her role, Mélanie can count on a cohesive team that works closely together to successfully advance projects related to regulatory dossier and drug lifecycle management, ensuring the products’ quality, efficacy, and safety and helping make them available to Canadian patients.
