Built by people who lived
GxP compliance.

Jose Caraballo Oramas is a biopharmaceutical quality and compliance executive with more than 40 years of experience across pharmaceutical manufacturing, biotechnology, and cell and gene therapy. He has held leadership roles at Abbott, Bayer, Amgen, and Kite, a Gilead company, most recently as Vice President of Global Compliance, Quality Systems & Quality Engineering.

He is Founder and Principal of JCO Global Advisory LLC, advising life-sciences organizations on GxP quality, compliance, validation, inspection readiness, governance, and the responsible use of AI in regulated environments. At Qualisera, he brings the perspective of a senior industry leader to how technology can support credible, practical, and compliant quality and regulatory workflows.

Abhishek brings more than 20 years of experience across the software, healthcare, and life sciences industries, including at Merck, McKesson, Thermo Fisher Scientific, and Gilead Sciences. His work across innovative technology implementations, computer system validation and assurance (CSV/CSA), automation, cybersecurity, vendor assessment, and inspection readiness gives him a unique perspective on the challenges regulated industries face.

He is passionate about the controlled use of AI in regulated work and speaks regularly at industry conferences on IT compliance and the use of AI in GxP environments. He founded Qualisera to give quality, regulatory, and compliance teams focused AI tools that hold up in an inspection: cited, reviewed by a person, and recorded.