Experienced GXP quality leader with a strong background in biologic, drug, and cell therapy development. Accomplished in establishing and managing phase-appropriate Global Quality Management Systems, ensuring alignment with FDA, EMA, and global regulations. Notable achievements include successful IND, IMPD, NDA, and MAA submissions, hosting regulatory inspections, and saving millions through investigative efforts. Skilled in implementing risk-based assessments, overseeing QA/QC for manufacturing, CDMOs, clinical labs, and CROs. Proficient in microparticle and inhalation delivery systems. Current roles include founding a GXP consulting firm and serving as the Vice President of QA at a CDMO. Extensive publication and industry involvement.