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Profile Details
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USD 120 /hr
Hire Sherri H.
United States
USD 120 /hr
Clinical Quality Assurance Consultant with 20+ years experience with FDA, EMA and other regulators including Clinic
Profile Summary
Subject Matter Expertise
Services
Writing
Clinical Trial Documentation
Research
Fact Checking,
Gap Analysis
Consulting
Operations Consulting,
Scientific and Technical Consulting,
Regulatory Consulting
Product Development
Quality Assurance & Control (QA/QC)
Work Experience
Director, Clinical Quality Assurance
Vera Therapeutics
May 2024 - March 2026
Senior Director, GCP Quality Assurance
Eiger Biopharmaceuticals
December 2021 - March 2024
Senior Director, GCP Quality Assurance
Myovant Sciences
May 2021 - September 2021
Director, Vendor Compliance
Gilead Sciences
January 2019 - January 2021
Senior Director, U.S., QA, Risk & Compliance
Premier Research
May 2008 - June 2018
Program Manager (equivalent to IRB Administrator)
IRB & Human Research Mgt (formerly RCRC IRB owned by PPD)
October 2006 - May 2008
Associate Director, Clinical Quality Assurance
PPD
September 1998 - October 2006
Consumer Safety Officer
US FDA
December 1989 - September 1998
Education
Bachelor of Science
Texas Woman's University - United States
May 1978 - May 1980
Certifications
- Certification details not provided.