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Amanda McCulloch Location
Saint Paul, MN, US
Amanda McCulloch Work
2026 -now Senior Director, Quality and Compliance @
2023 -2026 Director, Global CRO Quality @
2020 -2023 Director, Global Clinical Quality @
2015 -2020 Manager and Senior Manager, Clinical Quality @
2006 -2015 Senior and Principal Clinical Quality Specialist @
2004 -2006 Clinical Research Manager @
2003 -2004 Senior Clinical Research Coordinator @
2000 -2003 Clinical Research Coordinator @
Amanda McCulloch Education
Bethel University
Master of Business Administration - MBA (Strategy and Leadership)
Concordia University-St. Paul
Bachelor of Arts (BA) (Natural Science)
Amanda McCulloch Skills
Regulatory Audits
Corrective and Preventive Action (CAPA)
ISO 14155
Internal Audits
Project Management
Quality Assurance
People Development
Cross-functional Team Leadership
Business Process Improvement
Process Improvement
Training
Clinical Research
Clinical Trials
Medical Devices
FDA
GCP
Trial Management
ICH-GCP
Healthcare
Quality System
Organizational Effectiveness
Collaboration
Regulatory Requirements
Clinical Development
Data Management
Regulatory Affairs
CAPA
ISO 13485
Sop
21 CFR Part 11
Good Clinical Practice (GCP)
U.S. Food and Drug Administration (FDA)
B2C Marketing
Time Management
Performance Management
Microsoft Excel
Pivot Tables
Data Visualization
Data-driven Decision Making
Competitive Strategies
Global Strategy
Strategic Thinking
Resiliency
Leadership
Ich Gcp
Strategic Planning
Compliance
Ophthalmology
Microsoft Office
Microsoft Word
Clinical Quality
Customer Service
Research
Organizational
Amanda McCulloch Summary
Amanda McCulloch, based in Saint Paul, MN, US, is currently a Senior Director, Quality and Compliance at Heart Rhythm Clinical Research Solutions. Amanda McCulloch brings experience from previous roles at NAMSA and Medtronic. Amanda McCulloch holds a Master of Business Administration - MBA in Strategy and Leadership @ Bethel University. With a robust skill set that includes Regulatory Audits, Corrective and Preventive Action (CAPA), ISO 14155, Internal Audits, Project Management and more. Amanda McCulloch has 2 emails and 2 mobile phone numbers on RocketReach.
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