Brian Yun

I’m a high-impact clinical operations & quality systems leader with a 7+ year trajectory in regulatory compliance and clinical systems architecture. I specialize as a LIS System Owner, engineering global SOP frameworks and keeping organizations inspection-ready through disciplined, risk-based execution.

As Manager, Sample Management at BIOAGILYTIX LABS, I direct a workforce of 60+ staff across Boston, Hamburg, and Melbourne. I unified disparate local workflows into a single global SOP framework, eliminating site-specific inefficiencies to deliver faster, consistent throughput. During emergency testing contracts, I scaled daily intake from 700 to 2,700 samples per day while maintaining a strict 24-hour turnaround time. I also led front-line defense for 50+ inspections (FDA, CAP, EMA, Sponsors), managing observations to closure via deviation documentation and CAPA—driving zero repeat findings and full retention of accreditation.

I serve as the Boston Site Lead for Laboratory Information Systems (LabVantage, Watson, Orchard Harvest). I own configuration for new study protocols, hardware infrastructure (scanners/printers), and data integrity, ensuring that operational decisions translate into compliant, reliable system behavior across studies.

Earlier in my career, as a Laboratory Technician at REPROSOURCE, INC., I executed GLP/GCP-compliant sample processing for a specialized fertility diagnostics laboratory, building strong foundations in high-volume commercial testing workflows and regulatory documentation. I’ve also contributed through board leadership and safety committee work, supporting community safety protocols and governance decisions, and I continue strengthening my operational and compliance approach through my B.S. in Healthcare Administration at Northeastern University.