Amlan Dutta is Head of Quality for the Rare Disease, Oncology & Immunology Cluster at Sanofi, overseeing quality operations across sites in the U.S., France, and Germany. Previously, he led Sanofi’s Global Quality for Cell and Gene Therapy, managing quality across internal and external manufacturing. Before Sanofi, Amlan was SVP of Quality & Compliance at Celularity, where he led GxP quality and supported commercial supply and clinical development for allogeneic cell therapies. He also held leadership roles at Spark Therapeutics, scaling quality operations and advancing inspection readiness for gene therapies. Earlier, Amlan led biologics quality at Bristol Myers Squibb and supported the Celgene integration, following over 15 years at Merck across biologics, clinical supply, and vaccine operations. With expertise spanning GxP, regulatory inspections, and the development of biologics, vaccines, cell and gene therapies, and small molecules, Amlan has led BLA submissions, commercial launches, and major quality transformations across the industry.