Rose Xu, Ph.D.
Vice President, Global Quality
As Vice President and Head of Global Quality, Rose Xu leads global product quality for Altruist, providing strategic oversight of quality systems, manufacturing quality, regulatory inspection readiness, and commercialization to ensure compliance with global regulatory standards and support the successful delivery of high-quality medicines to patients worldwide.
Prior to her role at Altruist, Rose Xu joined Innovent Biologics as Vice President and Head of Global Product Quality in December 2025. She brings nearly 20 years of experience at the U.S. FDA, including five years in medical device review and 15 years in regulatory review of drug products, with expertise in Chemistry, Manufacturing, and Controls (CMC) as well as facility compliance. Throughout her FDA career, she conducted and supported numerous domestic and international inspections and regulatory assessments, contributing to the approval and lifecycle oversight of both small molecule and biologics products. She also played a key role in developing FDA internal policies and regulatory guidance documents.
Before joining the FDA, Rose gained 10 years of industry experience in pharmaceutical research and development, providing her with a strong understanding of product development across the entire lifecycle. She holds a bachelor’s degree from Fudan University School of Medicine, a master’s degree from Arizona State University, and pursued her Ph.D. studies at Johns Hopkins University School of Medicine.
