Jose A. Caraballo

Jose Caraballo is a Biotech/biopharma executive with extensive quality, development, and manufacturing expertise. As VP of Corporate Quality, he directs and oversees global compliance, global quality systems, and global quality engineering functions for Kite Pharma, a Gilead company. Previous roles include Head of Bayer’s Corporate Quality Audit and Inspections – Americas, Quality Lead for Bayer’s Cell Culture Technology Center, Global Product Quality Lead, Director of Global Quality Biotech, Director of Validation, and Director of Quality Operations for a Fill and Finish facility. In addition, he is experienced in Global Team Leadership, MSAT, Process Optimization, Manufacturing Operations, Technology Transfers, Facility Start-ups, GxP Compliance, and Regulatory Submissions from multiple roles in development, quality, and manufacturing at Bayer, Amgen, and Abbott Laboratories.
He currently serves as a member of the PDA Advanced Therapy Medicinal Products Advisory Board (ATMP AB), member of the PDA Biopharmaceutical Advisory Board (BioAB), a member of the Editorial Board of the PDA Journal of Pharmaceutical Science and Technology, and a member of the ISPE Guidance Documents Committee (GDC). He holds ASQ CQA, CQE, and CQM/OE certifications and has authored ISPE Guides on Cleaning Validation, Technology Transfer, and Autologous Cell Therapies.
Jose holds Master's and Bachelor's degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix.