Jackie Torfin

CEO & Principal Advisor

Jackie Torfin - CEO and Principal Advisor for QLeaR Advisors

Jackie’s QLeaR Advantage

My Why: I started my career as a Medical Technologist in the clinical laboratory with the goal of being involved in the medical space as much as I could.  I moved into industry to further this goal, learning as much as I could about the business of medical devices and pharmaceuticals. It turns out I’m pretty good at understanding regulations, interpreting their application, and designing and writing great systems. Maybe I should have been a lawyer?

My Favorite Project: Creating the first global system for a multinational company in the medical device space.  No one loved the quality; each site believed they were “the gold standard,” and there was no other global function in the company. In 2 years, my team and I created a fully functioning global quality and regulatory team, brought other organizations like purchasing and development along with us (they globalized, too!), and implemented an automated QMS to provide seamless movement of personnel and projects between 7 sites in 5 countries. I’m still close with many from that team today.

Areas of Focus: Mentoring and Supporting Compliance Leadership, Inspection Readiness, Audits and Gap Assessments, Remediation, Due Diligence, GCP, GLP, GMP, Medical Devices, IVD, Pharmaceuticals, Biologics, HCTP

Years of Experience: 34

Education and Certifications:

  • B.S., Medical Technology
  • M.A., Leadership
  • MT (ASCP)
  • CQA (ASQ)
  • ISO Lead Auditor (SGS)