Kathy Azuara has over 30 years of experience leading clinical and commercial global biopharmaceutical Quality organizations. Her areas of expertise include quality assurance, quality systems, quality compliance, M&A due diligence, post-merger integrations, CMC and facility licensing strategy, and cGMP operations for biologics, gene therapy, and medical devices.
Prior to consulting, Kathy held senior leadership Quality Assurance roles at Ultragenyx, Alexion, Shire, Baxalta, and Baxter. She is known for her strategic and risk-based approach to regulatory compliance and oversight of manufacturing and quality control operations. She has led numerous new cGMP facility start-ups and managed hundreds of regulatory inspections with the FDA, PMDA, MHRA, HPRA, ANVISA, and other regulatory bodies. She is experienced with large-scale quality system transformations and significant compliance remediation efforts, including consent decree and warning letter management.

EDUCATION

University of Wisconsin – Madison
BS, Bacteriology