Anisa Gandhi

Director, Quality Systems and Compliance @Moderna

Canton, MA, US
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Aug 2021 — Present

Director, Quality Systems and Compliance @Moderna

View department →

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

N/A

Illinois State University

Bachelors of Science, Chemistry

SKILLS

Wet ChemistryLaboratoryPharmaceutical IndustrySopChemistryValidationChange ControlLimsGmpRegulatory RequirementsQuality AssuranceManagementGlpCapaTestingChromatographyQuality AuditingFdaTrainingAseptic ProcessingUv/VisHplc21 Cfr Part 11Analytical Chemistry

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.

Anisa Gandhi — Director, Quality Systems and Compliance at Moderna in Canton, MA, US | Unifers