Experience

Tanvex Biopharma USA, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• VP, Regulatory

  • Feb 2023 - Present

• VP Quality, Planning/CMC Regulatory

  • 2018 - Feb 2023

• Director, Drug Product development and Manufacturing

  • 2017 - 2018

• Director of Project Management

  • Jul 2014 - 2018

• Head of Quality

  • Jan 2012 - 2017



Actavis plc (now Allergan)

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Manager, Corp. Quality and Compliance

  • Jan 2001 - Dec 2011

  5+ FDA PAI including FDA foreign inspections, 3 had zero 483 observations, & all inspections received application approval recommendation. Compliance monitoring, internal audits, training, deviation, change control, CAPA, vendor audits, due diligence audits, pharmacovigilance audits, DEA inspections. 5+ FDA PAI including FDA foreign inspections, 3 had zero 483 observations, & all inspections received application approval recommendation. Compliance monitoring, internal audits, training, deviation, change control, CAPA, vendor audits, due diligence audits, pharmacovigilance audits, DEA inspections.



Novartis Canada

• Sr. Technical Services Specialist

  • 1996 - 2000

  Member of Integration Task Force team that developed transfer strategies and completed site transfer of over 80 products/strengths in less than three years. Managed technology transfer projects and the process validation activities (MVP, SOP, Protocols/reports) for various dosage forms, i.e. solid, liquid, and semi-solid. Implemented site cleaning validation program. Conducted annual product review per FDA requirement., Managed stability program (SOPs, test methods, study protocols) on products… Show more Member of Integration Task Force team that developed transfer strategies and completed site transfer of over 80 products/strengths in less than three years. Managed technology transfer projects and the process validation activities (MVP, SOP, Protocols/reports) for various dosage forms, i.e. solid, liquid, and semi-solid. Implemented site cleaning validation program. Conducted annual product review per FDA requirement., Managed stability program (SOPs, test methods, study protocols) on products for development, NDA and validation batches. Show less Member of Integration Task Force team that developed transfer strategies and completed site transfer of over 80 products/strengths in less than three years. Managed technology transfer projects and the process validation activities (MVP, SOP, Protocols/reports) for various dosage forms, i.e. solid, liquid, and semi-solid. Implemented site cleaning validation program. Conducted annual product review per FDA requirement., Managed stability program (SOPs, test methods, study protocols) on products… Show more Member of Integration Task Force team that developed transfer strategies and completed site transfer of over 80 products/strengths in less than three years. Managed technology transfer projects and the process validation activities (MVP, SOP, Protocols/reports) for various dosage forms, i.e. solid, liquid, and semi-solid. Implemented site cleaning validation program. Conducted annual product review per FDA requirement., Managed stability program (SOPs, test methods, study protocols) on products for development, NDA and validation batches. Show less



Laboratoire Nationale du Vaccine Veterinaire

• Head of QA/QC

  • Nov 1988 - Sep 1994