Anisa Gandhi
Director, Quality Systems and Compliance @Moderna
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WORK HISTORY
Director, Quality Systems and Compliance @Moderna
Ensure quality oversight for the development, communication, implementation, maintenance and execution of the Quality Management System. • Work collaboratively with all GMP functions to identify and initiative proactive and continuous improvement activities. • Sustain robust and efficient programs and processes to ensure GMP compliance with regulatory requirements and company objectives and quality policies. • Facilitate Quality Management Review, monitor KPI metrics, identify trends and initiate improvement projects • Maintain regulatory surveillance and continuous benchmarking with other industries to ensure GMP compliance • Host Health Authority and partner inspections of Norwood, MA facility, generate appropriate corrective actions where gaps were identified from company policy/standards • Maintain and improve upon GMP training program, internal inspection program, document management program, and Quality Assurance Validation program to support Norwood, MA manufacturing site
EDUCATION
Illinois State University
Bachelors of Science, Chemistry
SKILLS
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