Sereen Morgan-Murray

Background

About Sereen Morgan-Murray

A seasoned exFDA BIMO Investigator(over 6 years), creative, problem-solver, and highly motivated with an international mindset. With combined 14-plus years of progressively increasing responsibility and accountability spans across several roles within the Research (both clinical and non-clinical)/ GCP compliance/Clinical Quality Assurance/ Regulatory in which GCP views have been shaped by serving in these several roles. The top requested skills managing/ training junior professionals in conducting Mock Regulatory inspections/Investigations, facilitating the CAPAs elaboration and follow-up, authoring/co-authoring SOPs, and auditing clinical trials data ( Site Clinical Investigator, CRO, GLP/GCLPS, IRBs, and Sponsors), Inspection Management- to lead in the preparation, facilitation, and follow-up of inspections by national and international regulatory authorities, escalate serious/non-compliance issues as appropriate, supporting domestic and international clinical trials through quality oversight program, and provide compliance consulting with team. Key accomplishments include completing over 100 independent complex domestic and international FDA-BIMO-related Inspections/Investigations some of which resulted in an FDA483 issued during the closeout with a final determination from the FDA Center of a Warning Letter.