Jose Caraballo
Vice President Quality Kite Pharma Inc
Jose Caraballo Oramas is a biopharmaceutical quality and manufacturing leader with more than 30 years of experience across engineering, manufacturing, and quality in regulated environments. He served as Vice President of Quality Compliance, Quality Systems, and Quality Engineering at Kite Pharma, where he led global quality initiatives supporting the manufacture of autologous CAR-T cell therapies. His work focuses on manufacturing readiness, quality system governance, and scalable operating models for advanced therapies. He advises organizations on operational readiness and quality system design for biopharmaceutical and advanced therapy manufacturing. Jose serves on the Board of Directors of the International Society for Pharmaceutical Engineering (ISPE) and on the PDA Advisory Board for Advanced Therapy Medicinal Products (ATMPs).
Seminars
- Debating whether commercial manufacturing should prioritize commercial scalability from day one or focus on the fastest path into the clinic, and how each choice shapes regulatory strategy
- Examining how early process design and analytical development decisions impact potential CMC approval for commercial studies
- Evaluating where automation delivers the greatest operational value in CAR-T manufacturing processes
- Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
- Establishing governance and validation strategies to ensure reliability and regulatory readiness as manufacturing scale
