Kathi Shah Email & Phone Number
SVP, Corporate Development and Compliance @ BrainChild Bio
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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
- 21 CFR Part 11
- CAPA
- CRO
- CRO Management
- Clinical Development
- Clinical Trials
- Corrective and Preventive Action (CAPA)
- Cross-functional Team Leadership
- Design Control
- FDA
- Good Clinical Practice (GCP)
- Healthcare
- ICH guidelines
- ICH-GCP
- ISO 13485
- ISO 14155
- Lean Business Processes
- Manufacturing
- Medical Devices
- Start-ups
- Strategic Planning
- Strategy
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Corrective and Preventive Action Capa
- Customer Service
- Project Management
- Good Clinical Practice Gcp
- Ich Gcp
- Cross Functional Team Leadership
- R
- u.s. Food and Drug Administration 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 21 CFR Part 11, CAPA, CRO, CRO Management, Clinical Development and more. Kathi Shah has 3 emails and 1 mobile phone numbers on RocketReach.
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