Experience

Onkos Surgical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Vice President, Quality and Regulatory

  • Nov 2019 - Present

• Sr. Director, Quality Assurance and Regulatory Affairs

  • Feb 2019 - Nov 2019

• Sr. Director, Quality Management Systems and Training

  • Apr 2018 - Jan 2019



PENTAX Medical Americas

• United States
• Medical Device
• 200 - 300 Employee

• Director, Quality Systems and Compliance

  • Apr 2015 - Apr 2018

• Sr. Manager, Quality Management Systems

  • Feb 2014 - Apr 2015

  Assure the overall health, sustainability, and improvement of the Quality Management System. Owner of Management Review, Complaint, CAPA, Internal Audit, and External Audit processes.



LifeCell, An Acelity Company

• United States
• Biotechnology Research
• 200 - 300 Employee

• Sr. Manager Quality Systems

  • Feb 2011 - Feb 2014

  Direct a team of Quality Engineers responsible for ensuring the quality of nonconformances (NCRs), quality investigations, and resulting CAPA. Ensure compliance and establish the overall strategy for the CAPA Quality System. Assure the Quality Management System is maintained and improved by leading the management review process. Direct a team of Quality Engineers responsible for ensuring the quality of nonconformances (NCRs), quality investigations, and resulting CAPA. Ensure compliance and establish the overall strategy for the CAPA Quality System. Assure the Quality Management System is maintained and improved by leading the management review process.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Process Informatics

  • 2009 - Feb 2011

  Managed a team of engineers/scientists to ensure the continuous monitoring and improvement of manufacturing processes. Partnered with key stakeholders to identify, prioritize, and manage the implementation of process improvements. Designated as the site lead for the Prevenar13 E2E (End to End) which utilized Lean/Six Sigma tools to drive quality improvements and ensure reliable supply.

• Manager, Validation

  • 2006 - 2009

  Led a team of validation personnel supporting syringe/vial filling and packaging processes. Key areas of focus were Equipment Qualification, Process Validation, Media Simulation, and Cleaning Validation. Partnered with Research and Development and the Technical Transfer team to ensure the successful commercialization of a new vaccine process.

• Sr. Compliance Manager

  • 2003 - 2006

  Managed a team of investigators, document control, and other personnel supporting the Pneumococcal Polysaccharide Fermentation and Purification processes. Implemented and led an investigations team to reduce number of overdue investigations from 141 to 0 in less than three months. Facilitated the departmental documentation, CAPA, and change control processes attaining target closure dates and eliminating overdue records.

• Sr. Lead Investigator

  • 2002 - 2003

  Authored comprehensive manufacturing investigations for a cGMP fermentation and purification facility. Identified and implemented corrective and preventive actions (CAPA) based on investigation findings.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Manufacturing Supervisor

  • 2000 - 2002

• Engineer

  • 1999 - 2001

• MMDP Analyst

  • 1997 - 1999