John Y. Lee, MBA, BA

John Y. Lee, MBA, BA

GMP Compliance Advisor

• Specializing in:
  • Pharmaceutical GMP compliance consulting
  • Pharmaceutical GMP compliance auditing
  • Quality assurance
  • Qualification and validation
  • GMP compliance training
• Professional experience:
  • Director, Quality Assurance
    Altana, Inc.
  • Director, Quality Assurance
    Organon, Inc.
  • GMP Compliance Associate
    Ortho Pharmaceuticals
  • Consumer Safety Officer (Investigator)
    U.S. Food & Drug Administration
    East Orange, New Jersey
• Mr. Lee has lectured and published extensively on the topics of GMP compliance and auditing, quality assurance, validation, lyophilization, aseptic processing and filtration, clean rooms and pre-approval inspections