Jose Caraballo
Kite, a Gilead Company.
VP Quality Systems, Compliance, and Quality Engineering
Jose Caraballo serves as Vice President of Quality Systems, Compliance, and Quality Engineering at Kite Pharma, a Gilead Company, where he supports global quality systems, regulatory compliance, quality engineering and digital transformations across Kite's manufacturing network.
An ISPE member since 2010, Jose has been actively engaged with the Greater Los Angeles Area Chapter and has participated as a speaker at multiple ISPE conferences and workshops. He currently serves as Co-Chair of the ISPE Guidance Documents Committee and as an Editorial Reviewer for Pharmaceutical Engineering magazine. His volunteer leadership includes coauthoring multiple ISPE guidance documents, including Cleaning Validation Lifecycle: Applications, Methods, and Controls (Co-Chair), Technology Transfer (3rd Edition), Advanced Therapy Medicinal Products - Autologous Cell Therapy, Advanced Therapy Medicinal Products - Allogeneic Cell Therapy, and Baseline Guide Vol. 6: Biopharmaceutical Manufacturing Facilities (3rd Edition).
With over 40 years of experience in the pharmaceutical and biotechnology industries, Jose has held leadership roles in operations, development, and quality at companies including Abbott Laboratories, Amgen, Bayer, and Kite, a Gilead Company. He has led or participated in hundreds of audits, due diligence assessments, and regulatory inspections globally. Jose holds certifications from the American Society for Quality (ASQ) as a Certified Quality Auditor, Certified Quality Engineer, and Certified Manager of Quality/Organizational Excellence. He earned BS and ME degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix.
Jose envisions ISPE as a global catalyst for advancing pharmaceutical science and operations. He believes ISPE must lead in embracing emerging technologies, including Al, data analytics, and automation, while maintaining its legacy of quality and compliance.
An ISPE member since 2010, Jose has been actively engaged with the Greater Los Angeles Area Chapter and has participated as a speaker at multiple ISPE conferences and workshops. He currently serves as Co-Chair of the ISPE Guidance Documents Committee and as an Editorial Reviewer for Pharmaceutical Engineering magazine. His volunteer leadership includes coauthoring multiple ISPE guidance documents, including Cleaning Validation Lifecycle: Applications, Methods, and Controls (Co-Chair), Technology Transfer (3rd Edition), Advanced Therapy Medicinal Products - Autologous Cell Therapy, Advanced Therapy Medicinal Products - Allogeneic Cell Therapy, and Baseline Guide Vol. 6: Biopharmaceutical Manufacturing Facilities (3rd Edition).
With over 40 years of experience in the pharmaceutical and biotechnology industries, Jose has held leadership roles in operations, development, and quality at companies including Abbott Laboratories, Amgen, Bayer, and Kite, a Gilead Company. He has led or participated in hundreds of audits, due diligence assessments, and regulatory inspections globally. Jose holds certifications from the American Society for Quality (ASQ) as a Certified Quality Auditor, Certified Quality Engineer, and Certified Manager of Quality/Organizational Excellence. He earned BS and ME degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix.
Jose envisions ISPE as a global catalyst for advancing pharmaceutical science and operations. He believes ISPE must lead in embracing emerging technologies, including Al, data analytics, and automation, while maintaining its legacy of quality and compliance.