Director of Quality Assurance with over 25 years of experience in the pharmaceuticals industry. Skilled and well versed in GMPs, QMS, Vendor Qualification Programs, Maintenance Programs, Environmental Monitoring, Internal and External Auditing Programs, Serialization and Aggregation of Pharmaceutical products, and Risk Management. I have demonstrated success in leading with a pharmaceutical product through development and transferring to a commercial product interacting with other teams, monitoring and assessing all key factors with GXP awareness and focus.