
Gisele Desrochers
Quality Assurance professional specializing in Quality Management Systems, including: - QMS consulting (auditing, rescue, restructure and build) - Oversight of... | Seattle, Seattle, United States
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Gisele Desrochers’s Emails gd****@fr****.org
Gisele Desrochers’s Phone Numbers No phone number available.
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Gisele Desrochers’s Location Seattle, Seattle, United States
Gisele Desrochers’s Expertise Quality Assurance professional specializing in Quality Management Systems, including: - QMS consulting (auditing, rescue, restructure and build) - Oversight of the QMS for Statistical & Data Management Centers, CROs working in the clinical trials industry. - Oversight of a Quality Assurance Department, including programs for internal audit, vendor audit, vendor oversight, system validation, change control, risk management, document control, staff training, incident/event reporting and CAPAs. - Preparing for and hosting regulatory inspections and client audits - Global and department strategic planning and budgeting - Providing guidance regarding regulatory expectations and industry best practices - Planning projects and driving them to completion - Compliance with Quality Assurance and regulatory requirements for NIH, FDA, EMA, ICH GCP, CFRs - Configuration and implementation of eQMS system, MasterControl, and eTMF system, Veeva Vault. - Supervision of and directing work of Quality Teams - Debarment checks, client satisfaction surveys, as well as, maintenance of CVs, JDs and org charts for inspection readiness
Gisele Desrochers’s Current Industry Fred Hutch
Gisele
Desrochers’s Prior Industry
University Of Washington
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Centers For Disease Control And Prevention Phfe
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Seattle Cancer Care Alliance
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Bloodworks Northwest
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Darigold
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Axio Research
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Fred Hutch
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Work Experience

Fred Hutch
Director, Quality Assurance
Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Fred Hutch
Senior Manager, Quality Assurance
Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Fred Hutch
Manager, Quality Assurance
Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Apr 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Axio Research
Manager, Quality Assurance
Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Darigold
Supervisor, Quality Assurance
Tue Feb 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Aug 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Bloodworks Northwest
Quality Operations Specialist
Sun Aug 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Seattle Cancer Care Alliance
Quality Operations Specialist
Mon Dec 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jun 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Centers For Disease Control And Prevention Phfe
Federal Biologist GS-09, Microbiologist 3 - Seattle BioWatch
Sat May 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jul 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
University Of Washington
SPS Lab Tech
Sat Mar 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat May 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)