John Y. Lee

John Y. Lee, MBA, BA

GMP Compliance Advisor

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

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