Director R and D and PV Quality Assurance @ (March 2023 - April 2024)
Associate Director Quality Assurance @ (January 2019 - March 2023)
Sr. Manager, GCP QA @ (April 2017 - January 2019)
Associate Director, GCP Americas @ (January 2013 - April 2017)
Director, GCP Services @ (July 2011 - January 2013)
Manager, GCP Services @ (December 2010 - July 2011)
Manager, GCP Compliance @ (December 2009 - December 2010)
Sr. Auditor @ (May 2003 - December 2009)
Sr. GCP Compliance Auditor @
Sr. GCP Compliance Auditor @ (January 2000 - December 2003)
Research Data Coordinator, Data Management @
Research Data Coordinator, Data Management @ (January 1998 - December 2000)
Amy Hansen Education
Illinois State University
Bachelor Of Science (Management)
Savanna High School
Amy Hansen Skills
Regulatory Requirements
ICH
CSRs
Pharmacovigilance
Issue Management
Consulting
Auditing
Microsoft Office
Rare Diseases
Oncology Clinical Research
Quality System
GVP
Regulatory Compliance
Internal Audits
Clinical Quality
Corrective and Preventive Action (CAPA)
GCP
Regulatory Affairs
FDA
Clinical Development
Clinical Trials
Regulatory Submissions
Oncology
Sop
Pharmaceutics
Drug Development
Data Management
GLP
Medical Devices
Quality Assurance
Clinical Study Design
Pharmaceutical Industry
Validation
CRO
Endocrinology
EDC
Biotechnology
21 CFR Part 11
CTMS
Clinical Research
Biotechnology Industry
Inspection Readiness
Clinical Trial Management System (CTMS)
CRO Management
Electronic Data Capture (EDC)
Good Clinical Practice (GCP)
Quality Management
GxP
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Amy Hansen Summary
Amy Hansen, based in Bettendorf, IA, US, is currently a Senior Director, Quality GCP at Verastem Oncology. Amy Hansen brings experience from previous roles at Alnylam Pharmaceuticals and PAREXEL. Amy Hansen holds a Bachelor Of Science in Management @ Illinois State University. With a robust skill set that includes Regulatory Requirements, ICH, CSRs, Pharmacovigilance, Issue Management and more. Amy Hansen has 2 emails and 2 mobile phone numbers on RocketReach.
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