Director Quality Management
- Quality Assurance, Good Practices
- French health agency/inspection
Sophie has extensive experience in quality assurance, pharmaceutical quality and regulatory compliance gained through more than 25 years of working within the pharmaceutical industry.
Sophie started her professional career in 1990 at MAYOLY SPINDLER as head of Quality Control and later as head of Production. She was also appointed QP deputy in the manufacturing site. She has gained practical and valuable experience in production, laboratory of control and release and also management of team.
In 1996 Sophie joined MENARINI FRANCE where her most recent role was as head of Quality Assurance and pharmaceutical Development. She was responsible for implementation a quality management system, conducting manufacturing audits, follow-up post-marketing stability and update of CMC part of registration dossier. She was appointed QP deputy of the “exploitant” site and developed relationships with scientific experts and French health agency.
In 2004 Sophie joined ROCHE FRANCE as Quality and Regulatory Compliance responsible and QP deputy. She was managing the coordination of transvers projects (opening new site, set up codification and Data Matrix, task force drug shortage) and of quality issues. She was piloting corporate audits and inspections and was contributing with her team to the continuous improvement of quality processes.
Through her experience, Sophie has gained a valuable experience in a range of French health agency interactions, particularly regarding inspections and quality issues topics and has developed her skills in terms of lead and management projects and teams.
After 25 years of experience in the pharmaceutical industry, Sophie moved to consultancy and joined BLUE-REG PHARMA CONSULT in April 2016.
Since November 2017, Sophie has been appointed “Pharmacien Responsable” (Qualifed Person) of PHARMA BLUE, subsidiary of BLUE REG.