Irma Maisonet

Background

About Irma Maisonet

Regulatory and Quality Operations Leader, BS in Pharmacy and over twenty-five years of professional experience with well known companies such as: Pfizer, Pfizer Pharmaceutical (formerly Wyeth, Searle), Abraxis Biosciences, Merck (formerly Schering Plough), Amgen, MOVA Pharmaceutical, OMJ, Sterling Pharmaceuticals and Bristol Myers Squibb. Positions held include: Assistant Director GCMC, Associate Director Quality Operations, MQA Manager, Regulatory/Quality Consultant, Acting Site Quality Director (QA/QCC), Regulatory Compliance & Quality Assurance Manager, Technical Services Coordinator, Quality Assurance Coordinator, Packaging Supervisor, and Pharmacy Warehouse Supervisor. Hands-on experience in Process Improvement, Validation, Change Control, GMP & Quality Systems Programs, Risk Assessment, FDA/Latin America Regulations, Operations and Laboratory procedures. Experience leading start-up processes for GCMC Hubs, Streamline initiatives within Quality and Regulatory Compliance and compliance enhancements programs under Consent Decree environment.