Xinyu Chen

Background

About Xinyu Chen

Quality professional with strong scientific and regulatory expertise and 18 years of experience in drug discovery and development, including small molecules, biologics, and advanced therapies (cell & gene) in both start-up biotech and big pharma environments. • Proven leader in building and scaling quality organizations from the ground up, designing phase-appropriate quality systems, implementing Electronic Quality Management Systems (EQMS), supporting internal and external manufacturing, managing suppliers and vendors, and qualifying GMP facilities to support clinical trials and regulatory submissions. • Highly experienced and dynamic leader with strong strategic thinking, innovative mindset, and abilities to bring organizational impact through collaboration and change management. • Demonstrated experience in building and leading high-performing quality teams to provide effective quality oversight while applying science-driven, risk-based approach to ensure quality and compliance across all GXP areas.