Michael Gatta has 15+ years of commissioning, qualification, validation (CQV) and quality experience and a total of over 20 years of experience in the pharmaceutical / biotechnology industry. Mr. Gatta has served as Senior Quality Assurance Consultant and Senior Validation Consultant for clients such as Shire and Sanofi/Genzyme in lead roles for Quality Risk Management (QRM) and CQV programs and projects. He has expertise in project planning, project resource management, and working within a consent decree environment.
Mr. Gatta has extensive knowledge in CQV, QRM, and quality systems policy and procedural development; CQV master plans; environmental qualification; airflow evaluations; sterilization processes; utility and process equipment qualifications; and TrackWise deviations and CAPAs.
Mr. Gatta has been a Principal with ICQ Consulting since 2011. Prior to joining ICQ Consultants, Mr. Gatta worked as a Validation Manager for Ipsen-Biomeasure. In his decade as a consultant prior, he was the Project Lead on numerous validation and qualification activities for clients such as AstraZeneca and Anika.
Mr. Gatta is an enthusiastic, goal-oriented professional who provides solution-focused, team-oriented leadership and enjoys working with internal staff and external customers to develop lasting and valuable working relationships.