JCO Global Advisory LLC
Founder and Principal
Jose Caraballo Oramas is Founder and Principal Advisor of JCO Global Advisory LLC, where he advises pharmaceutical and biotechnology organizations on organizational readiness, quality systems, regulatory compliance, operational governance, and leadership under scrutiny. He is also the creator of The BEACON Framework™, a leadership framework focused on building organizations that perform reliably under pressure, disruption, and regulatory oversight.
Most recently, Jose served as Vice President of Global Compliance, Quality Systems, and Quality Engineering at Kite Pharma, a Gilead Company, where he supported global quality systems, regulatory compliance, quality engineering, digital transformation, and inspection readiness across Kite’s manufacturing network.
An ISPE member since 2010, Jose currently serves on the ISPE International Board of Directors and is Executive Chair of the 2026 ISPE Annual Meeting & Expo. He also serves as 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 Volume 6: Biopharmaceutical Manufacturing Facilities (3rd Edition).
With more than 35 years of experience in the pharmaceutical and biotechnology industries, Jose has held leadership roles in operations, development, manufacturing, and quality at organizations including Abbott Laboratories, Amgen, Bayer, and Kite, a Gilead Company. He has led numerous global regulatory inspections, audits, due diligence assessments, technology transfers, and facility startup initiatives across complex biologics and advanced therapy manufacturing environments.
Jose holds certifications from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and Certified Manager of Quality/Organizational Excellence (CMQ/OE). He earned BS and ME degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix.
He is a frequent speaker and author on pharmaceutical quality, operational readiness, leadership, and the future of regulated manufacturing systems, including the evolving role of AI, digital systems, and organizational resilience in biopharmaceutical operations.
