Valerie Arnaudinaud-Lignier is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical, and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, Briefing Packages for Scientific Advice, CMC Variations, CTD module 3, and Quality Overall Summary of MAA/NDA.
With a strong industrial experience in Quality Control, Analytical Development, and Quality Assurance (GMP), Valérie contributes actively in the elaboration of product development plans and participates in the preparation of supportive documents such as stability and method validation reports, process optimisation/development reports. In addition, Valérie is able to manage subcontractors (C(D)MOs) and technology transfer. Thanks to her significant experience in the Pharmaceutical Industry, she can provide assistance and expertise for Quality Assurance aspects of projects such as verification of manufacturing licenses and GMP certificates, review of quality contracts and batch records, and audits of manufacturers. In addition, Valérie acts as a Qualified Person (Responsible Person) in Switzerland for the release of the drug products into the market. As such, she contributes to establishing, maintaining, and supervising the quality management system and maintains good knowledge of Swissmedic procedures and Swiss regulations including Good Manufacturing and Good Distribution Practices (GMP/GDP).
Valerie brings 12 years of experience in the Pharmaceutical Industry including 8 years at Théramex (a subsidiary of Merck KGaA then TEVA group), Monaco, and 4 years at Grimberg, a global French-based Company. She was in charge of the Quality Control (IMPs and marketed products) and Analytical Development of products in therapeutic areas such as gynecology, gastroenterology, otorhinolaryngology, and supplementation in mineral and vitamins. In addition, Valérie was responsible for maintaining and improving the Quality Management System in strong interaction with the Quality Assurance department as well as reviewing Quality and Service Agreements. In her function, she also prepared and attended Health Authority Inspections. In this role, Valérie gained experience in the chemistry of small molecules, analytical method development and validation, specification set-up as well as stability testing. She was involved in the pharmaceutical development, life-cycle management, and dossier authoring of many dosage forms such as solid (tablet, capsule), semi-solid (cream, gel), liquid (suspension, solution) and flexible (transdermal patch) forms.
Valerie earned an MSc in Physics and Chemistry and a Ph.D. in Pharmaceutical Sciences from the University of Bordeaux (France) in the field of polyphenol chemistry.
Valérie is based in Lausanne office.