Experience

Kala Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director, Quality Control

  • Nov 2017 - Present



Syner-G BioPharma Group

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Director, Head of Quality and Compliance

  • 2017 - 2017

  Responsible for providing strategic and tactical QA and cGMP support for pharmaceutical and biotechnology companies. Design and implement Quality Systems and strategies for efficient and compliant Quality Operations for companies operating in virtual/outsourced models. Responsible for providing strategic and tactical QA and cGMP support for pharmaceutical and biotechnology companies. Design and implement Quality Systems and strategies for efficient and compliant Quality Operations for companies operating in virtual/outsourced models.



Sunovion Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive Director, Quality Operations

  • Feb 2014 - 2016

  Leading the Quality Assurance, Quality Control, Validation and Product Complaint functions for Sunovion, for both development and commercial products. Responsibilities were for API through drug product and packaged products.

• Senior Director, Quality Assurance

  • Jul 2013 - Jan 2014

• Senior Director, Quality Assurance and Quality Control

  • Feb 2000 - Jun 2013

  A Senior Director of Quality Assurance and Quality Control with 20 years of broad experience in the pharmaceutical industry. Currently leads the quality organization for a manufacturing site, with exposure to Active Pharmaceutical Ingredient (API) sites worldwide. Responsible for API site quality systems, supply chain quality and commercial API release.



Raylo Chemicals

• Senior Technical Supervisor, Pilot Plant

  • 1996 - 2000

  •Oversaw technical matters in production, including operating instructions, batch review, deviation justification and monitoring of plant processes.•Part of production management team in pilot plant, responsible for on-call activities, daily prioritization and master batch record preparation.•Acted as the liaison operations and process staff, customers, quality and operations staff. •Oversaw technical matters in production, including operating instructions, batch review, deviation justification and monitoring of plant processes.•Part of production management team in pilot plant, responsible for on-call activities, daily prioritization and master batch record preparation.•Acted as the liaison operations and process staff, customers, quality and operations staff.