Gisele Desrochers
Director, Quality Assurance @Fred Hutch
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WORK HISTORY
Director, Quality Assurance @Fred Hutch
Member of the Senior Management Team, strategic planning - Oversight of the QMS for a Statistical & Data Management Center / CRO, clinical trials - Quality Assurance and regulatory compliance (NIH, FDA, EMA, ICH GCP)- Primary contact for regulatory inspections and client audits - Oversight of the internal audit, vendor audit, system validation, doc control, staff training, incident/CAPA programs, trial master files (TMF)- Configuration, implementation and primary sys admin for EQMS, MasterControl system and Veeva Vault eTMF system- Supervision of and directs work of Quality Assurance and TMF Specialists Teams - Misc: debar checks, system validation, client satisfaction surveys
EDUCATION
University of Washington
Bachelor of Science - BS, Microbiology
Art Institute of Seattle
Associate of Arts - AA, MV Business
Seattle Central Community College
Associate of Science - AS, Biotechnology
ABOUT GISELE DESROCHERS
PROFESSIONAL OVERVIEW & KEY ACCOMPLISHMENTS Director of Quality Assurance with 15+…
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