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Kathi Shah Location
Franklin, MA, US
Kathi Shah Work
SVP, Corporate Development and Compliance @ (February 2026 - Present)
SVP, Clinical and Business Operations @ (February 2024 - March 2026)
Owner and Principal @ LocKStep Consulting LLC (January 2021 - Present)
Vice President, Organizational Solutions @ (January 2019 - December 2019)
Principal Consultant @ (August 2015 - January 2019)
Senior Consultant @ (February 2014 - August 2015)
Senior Manager, Global Clinical Trial Operations @ (August 2010 - September 2013)
Manager, Clinical Trial Contracts and Payments @ (April 2009 - August 2010)
Project Manager @ (November 2004 - April 2009)
Process Development Engineer @ (October 2000 - November 2004)
Manufacturing Engineer @ Nova Biomedical (May 1999 - October 2000)
Kathi Shah Education
Babson F.W. Olin Graduate School of Business
MBA (Business)
2004-2008
Babson F.W. Olin Graduate School of Business
MS (Management)
2004-2008
Worcester Polytechnic Institute
BS (Biomedical Engineering)
1994-1999
Kathi Shah Skills
Corrective and Preventive Action Capa
21 CFR Part 11
CRO Management
Design Control
ISO 13485
Customer Service
Clinical Trials
Project Management
CRO
Good Clinical Practice Gcp
Ich Gcp
Healthcare
Strategy
Lean Business Processes
Manufacturing
CAPA
Clinical Development
Strategic Planning
Cross Functional Team Leadership
ICH guidelines
R
u.s. Food and Drug Administration Fda
Iso 14155
Medical Devices
FDA
Start Ups
u.s. Food and Drug Administration
Corrective and Preventive Action
Good Clinical Practice
Kathi Shah Summary
Kathi Shah, based in Franklin, MA, US, is currently a SVP, Corporate Development and Compliance at BrainChild Bio. Kathi Shah brings experience from previous roles at BrainChild Bio, LocKStep Consulting LLC and Halloran Consulting Group, Inc.. Kathi Shah holds a 2004 - 2008 MBA in Business @ Babson F.W. Olin Graduate School of Business. With a robust skill set that includes Corrective and Preventive Action Capa, 21 CFR Part 11, CRO Management, Design Control, ISO 13485 and more. Kathi Shah has 3 emails and 1 mobile phone numbers on RocketReach.
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