Gianie Roman-Soto

Gianie L Roman-Soto is a biopharmaceutical professional with over a decade of experience in pharmaceutical manufacturing, specializing in quality, compliance, and regulatory adherence. She has successfully led cross-functional teams, driven process improvements, and implemented key initiatives in cGMP compliance and data integrity, contributing to operational excellence across various drug production environments. Gianie holds several industry certifications, including Lean Six Sigma and OSHA, and is actively involved in professional organizations such as International Society of Pharmaceutical Engineering (ISPE) CaSA Emerging Leaders and the Healthcare Businesswomen’s Association (HBA). Passionate about empowering women and fostering diversity in manufacturing, she is dedicated to making a positive impact in her industry and continuously advancing her leadership expertise. Fluent in both Spanish and English, with basic knowledge of Italian, she brings a global perspective to her work and is currently exploring new opportunities with industry leaders.