Maggie Bernstein

Experience

1. Manager, Gmp Operational Quality

   Vertex Pharmaceuticals

   Feb 2022 — Present

   o Performs batch disposition functions and batch documentation archival for commercial small molecule products o Manages QA relationship with multiple CMOs o Reviews executed batch documentation from CMOs, including batch records, analytical release data, and Certificates of Analyses o Provides input, and reviews and approves product quality documentation such as Master Batch Records and test methods related to external manufacturing and testing of commercial drug product o Supports Quality Systems (Events, CAPA, Change Control) for lot release, continuous improvement, and regulatory compliance o Provides Quality input for root-cause analysis and product impact assessment for investigations due to Deviations, OOS and OOT events, ensuring appropriate CAPAs are identified as applicable o Collaborates with cross-functional teams to support process validation activities for drug product manufacturing, including site additions, scale-ups, and new product launch o Drafts, reviews, and approves (as applicable) Quality Agreements, SOPs, Work Instructions, test methods, specifications, validation protocols and reports, and other GMP documentation o Provides independent QA oversight for product tech transfer o Supports internal and regulatory audits, as well as new and periodic audits of CMOs o Analyzes batch release metrics and implements process improvements when necessary o Implements continuous quality improvements, including the development, validation, and launch of Veeva Vault Quality Management System o Provides ongoing support as Veeva Vault Trainer and Subject Matter Expert o Trains new and junior staff on batch record and analytical data review, quality systems, and CMO oversight

Education

• Northeastern University

  Masters of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

  2014 — 2017

• Salem State University

  B.A., History, Geography

  2006 — 2009