
Alex Yue, MBA
CO-FOUNDER- OWNS
- QUALITY, REGULATORY AND THE CUSTOMER CONVERSATION
- BUILT
- Quality management systems for implantable medical devices, biologics and small-molecule pharmaceuticals
- LED
- Inspections by the FDA, EMA, TGA, PMDA and NMPA, and by BSI and TÜV SÜD
- SEEN FROM
- Compliance, from the operational and the audit side
- RECOGNISED
- BSI-certified QMS Lead Auditor
- EDUCATION
- Executive Master in Change, INSEAD · MBA, University of New South Wales
Alex built his career in life sciences, where quality decides whether a product reaches a patient at all. In these most regulatory-demanding environments, he built and maintained the quality management systems that help companies produce implantable medical devices, biologics, and small-molecule pharmaceuticals including sterile injectables and radiopharmaceuticals. As head of quality for multiple companies, he led inspections by the FDA, EMA, TGA, PMDA and NMPA, and by notified bodies such as BSI and TÜV SÜD.
As a BSI-certified QMS Lead Auditor and a quality leader, he has seen compliance from both the operational and the audit side, including the industry’s open secret: the “read and understood” signature that documents training without ever delivering the learning. That experience shaped his conviction that compliance training has to build genuine competence, not just the paperwork that proves it happened.
With an Executive Master in Change from INSEAD and an MBA from the University of New South Wales, Alex pairs deep regulatory experience with the commercial and organizational perspective to scale neolumi where compliance pressure is greatest.