Michael Bergin
Executive Director, Quality @Verve Therapeutics
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WORK HISTORY
Executive Director, Quality @Verve Therapeutics
Boston, MA, US
Providing leadership and oversight for GxP QA for early stage gene editing clinical trials, including- Development and implementation of a phase-appropriate Quality Management System- Oversight of Quality Operations, Systems and Compliance Functions - Identifying and remediation of gaps or areas for improvement in systems, procedures, and quality initiatives - Collaboration with Manufacturing, QC, Process Development and R&D to ensure clinical supply and objectives are realized- Establishment and maintenance of Quality Technical Agreements with CDMOs and CTLs - Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs - Establishment and Execution of the Quality Risk Management system to identify and mitigate compliance risks
EDUCATION
Southern New Hampshire University
Bachelors Degree, Business Management/Organizational Leadership
SKILLS
ABOUT MICHAEL BERGIN
A well-rounded executive specializing in Quality/Regulatory oversight of Commercial/Clinical Quality Systems/Operations and Compliance programs supporting the manufacture of Cell and Gene, Solid/Liquid Oral dosage forms, Aseptic Biologics, Microbiome Therapeutics, and Medical Devices.
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