Michelle Bradley MBA CQA

Internal and External Aerie Quality Assurance Compliance Oversite and Management. Quality oversite of global external vendors through all phases of product development to commercialization. Serve as the quality team lead to ensure that Quality deliverables are provided on time, according to signed quality agreement(s) and global regulatory standards. Includes e.g., Quality agreements, GMP/ICH compliance auditing, review, and approval of supplier non-conformances, change controls, master and executed batch records, protocols, reports, analytical method development/transfer/testing activities etc. Final Quality review for Aerie CMC & GLP regulatory submissions