Jesse Hart, Msopm Email and Phone Number

The FDA Group, Westborough, MA RemoteConsultant, April 2024 - PresentClinCapture, Las Vegas, NV RemoteDirector of Quality and Regulatory Affairs, September 2020 - PresentAlcon, Fort Worth, TX RemoteProject Manager/Project Quality Manager, March 2019 – January 2022Aduro Biotech, Berkeley, CAIT Compliance September 2016 – January 2019CherryCircle Software, Austin, TX RemoteAuditor/Third Party Security Review, August 2018 - January 2019ON Semiconductor, Phoenix, AZ RemoteMedical Device Software Validation Adviser - March 2018 - January 2019ARC, Mill Valley, CA RemoteIT Compliance Services, August 2017 - October 2020Alcon a Novartis Company, Fort Worth, TX RemoteProject Quality Manager, December 2016 – December 2018SUNY The State University of New York, New York, NY RemoteData Management and Part 11 Consultant, March 2017 - July 2017Clinovo, Sunnyvale, CA RemoteAuditor for assessing compliance gaps, February, 2016 - August 2016Novartis, San Carlos, CAISRM Manager Tech Ops – Americas Region, December 2015 – July 2016Wincere, Sunnyvale, CAMobile Medical App Adviser & IT Compliance, February 2015 - December 2015Gilead Sciences, Foster City, CAProject Manager/Business Analyst, May 2015 – December 2015Gilead Sciences, Foster City, CALead System Life Cycle Consultant/Portfolio Manager, November 2014 – May 2015Alcon a Novartis Company, Fort Worth, TXValidation/Quality Manager, September 2014 – January 2015 Mosio, Inc., Part 11 Consultant, San Francisco, CA RemoteCompliance Officer, July 2014 – January 2018Alcon a Novartis Company, Fort Worth, TXSenior Project Quality Manager, May 2013 – May 2014Packaging Coordinators, Inc., Philadelphia, PAComputer System Validation Strategic Project Manager, January 2013 – May 2013

GENZYME, Framingham, MAManufacturing Systems & Information Technology Project Manager, January 2011 – January 2013Provided IT compliance and project management services for Framingham Biologics Manufacturing Systems IT projects in a Consent Decree environmentBIORELIANCE, Rockville, MDTechnical Project Manager, September 2010 – March 2011GENZYME, Framingham, MASite IT Compliance and Project Manager, March 2010 – September 2010Project Manager for all systems in Manufacturing Systems and Information TechnologyGENZYME, Framingham, MA/Lake Zurich, ILInfrastructure Qualification Execution and Project Manager, June 2009 – March 2010Project Management Office (PMO) member for the Genzyme MES Mission Critical Infrastructure ProjectBAXTER, Vernon Hills, ILValidation Lead, September 2008 – March 2009Managed three projects in a consent decree environmentMEDIMMUNE, Mountain View, CAComputer Validation Execution and Project Manager, June 2006 – August 2008Managed all computer validation projects for the three California sites

IT&E International, Chesterfield, MOPart 11 Program Manager - September 2004-May 2006PFIZER, Contractor for IT&E International, Chesterfield, MOSite Part 11 Project Manager, September 2004 – December 2005Site Project Manager for the Part 11 remediationSCHERING-PLOUGH, Contractor for RCM, Kenilworth, NJTechnical Remediation Team Lead for the Laboratory Part 11 Project, January 2004 – September 2004Managed the assessments and technical remediation of over 50 systemsPFIZER, Contractor for Venturi Partners, Holland, MILaboratory Systems Project Manager, April 2003 – January 2004Project manager for two system implementations for the Part 11 initiative ELI LILLY AND COMPANY, Contractor for PPD, Indianapolis, INValidation Project Leader, January 2003 - March 2003Project and Technical Leader for the validation of the laboratory automation systemsELI LILLY AND COMPANY, Contractor for Computer Horizons, Indianapolis, INValidation Technical Lead, , July 2001- January 2003iGENERON, Indianapolis, IN, IT Project ManagerProject manager and trainer for the implementation of all products, July 2000 - July 2001ELI LILLY AND COMPANY, Contractor for Xerox Connect, Indianapolis, INProject Manager, January 1999 - July 2000Managed the assessments and upgrades for over 100 lab automation systems