Biotechnology and Device industry professional with over 16 years of experience. Expert in Quality Management System Implementation and Application, particularly related to Annual Product Review (APR) and Management Review (MR) initiatives. Strong knowledge of global regulations and guidance related to cGMP, Biologics, Medical Devices and Combination Products. Skilled in the implementation of global programs, Product Management / Disposition activities, Six Sigma Methodology, and leading Quality Assurance operations.
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Project Leadership
ESQ Leadership
Led Multiple ESQ Management Responsibility Initiatives
Post Market Surveillance Leadership
Complaint / Product Security Investigation Lead
Annual Product Review (APR) Project Manager
Management Review (MR) Support
Project Leadership
Reference Standard / Critical Reagent Management
QC Support
Professional
Humanitarian
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