Career History

• GxP quality and auditing experience in the biopharmaceutical & medical device industry.
• Part of teams within various companies that brought several drug products to market from clinical trials to commercialization, including SEROSTIM®, HUMIRA®, VIGAMOX®, CIPRODEX®, HERCEPTIN®, HYLENEX®, MUCINEX®, AND XERMELO®.
• Subject Matter Expert for GxP quality and aseptic processing.
• Hosted numerous global regulatory agencies for drug Pre- Approval Inspections.