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Ann Leonard Location
Madison, WI, US
Ann Leonard Work
2022 -now Vice President Quality and Regulatory @
2022 -2022 Senior Director Of Quality @
2020 -2022 Director Of Quality @
2018 -2020 Global Quality Project Manager @
2015 -2018 Quality Engineer @
2013 -2015 Director of Material Quality @
2003 -2013 Medical Device Quality and Regulatory Compliance Consultant @ Self-Employed
2001 -2003 Director of Quality Systems @
1998 -2001 Quality System Coordinator @
Ann Leonard Education
Northeastern University
College of Professional Studies (Graduate Certificate in Biopharmaceutical International Regulatory Affairs)
2016-2018
Upper Iowa University
Master of Business Administration (MBA) (Quality Management)
2012-2013
Iowa State University
Bachelor of Science (B.S.) (Animal Science)
1990-1994
Ann Leonard Skills
FDA
Quality System
Medical Devices
Quality Management
CAPA
ISO 13485
Quality Control
Product Development
ISO
21 CFR Part 11
Regulations
CE marking
Complaint Management
Regulatory Requirements
Regulatory Affairs
Non-conforming product
21 CFR
Process Validation
EudraLex Guidance for Pharmaceutical Mfg
Life Sciences
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
ISO Standards
Change Control
Project Management
Employee Training
Ann Leonard Summary
Ann Leonard, based in Madison, WI, US, is currently a Vice President Quality and Regulatory at Elephas. Ann Leonard brings experience from previous roles at Elephas and Thermo Fisher Scientific. Ann Leonard holds a 2016 - 2018 College of Professional Studies in Graduate Certificate in Biopharmaceutical International Regulatory Affairs @ Northeastern University. With a robust skill set that includes FDA, Quality System, Medical Devices, Quality Management, CAPA and more. Ann Leonard has 2 emails on RocketReach.
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