At SANISURE, Iām streamlining change control and driving resolution of a two-year backlog of change records to improve record progression and QMS execution. I also manage the calibration program and respond to customer audit observations.
At AMGEN, INC., I supported deviations, change controls, CAPA, validation, and aseptic processing, and provided QA representation for FDA inspections and PAI readiness. At CAPSIDA BIOTHERAPEUTICS, INC., I built and led a GMP-ready Quality Management System for a gene therapy organization, supporting manufacturing readiness through controlled processes, training, and supplier quality.
