Smita Kurrumchand

Experience

• 

  McNeil Consumer Healthcare

  Mar 2013 - Apr 2015

  Managed and tracked system enhancements and bug fixes for the LabWare Laboratory Information Management systemPerformed risk assessments of business and functional requirements to determine criticality and develop scenarios for functional and user end testingDeveloped new and revised existing Standard Operating Procedures to accommodate system enhancements made through change requests submitted to the Change Control Review board Authored, reviewed and executed validation deliverables for multiple computer system upgrades (under FDA Consent Decree), throughout the planning, design/development and implementation phasesCollaborated with Quality Assurance and third party Regulatory Agency throughout each enhancement to ensure compliance with industry and company standards

  • Validation Engineer

    Aug 2014 - Apr 2015

  • Validation Analyst

    Mar 2013 - Jul 2014
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  Sanofi

  Apr 2015 - May 2018

  Business Operations Consultant

  Speaker Program Management platform (utilized by ~3000 field users) Subject Matter ExpertOperations Lead overseeing all system enhancements and integrations with internal and external partners and stakeholders; Reviewed and coordinated all data transfer and reporting for CMS (Centers for Medicare & Medicaid Services) submission for Speaker Programs under the Sunshine Transparency Reporting Act

• 

  Merck

  Jun 2018 - Jan 2019

  Information Technology Quality Assurance Consultant

  Performed Data Integrity assessments of multiple Laboratory Information Management systems and developed corresponding Data Integrity Remediation plans in collaboration with Merck's Data Integrity Center of Excellence (DI CoE).

• 

  Sanofi

  Jan 2019 - Jul 2019

  Senior Validation Engineer/Compliance Monitoring Consultant

  Speaker Program (Promotional Programs) monitoring which accounted for 30% of key controls monitored by the US Business Integrity & Compliance teamDeveloped and implemented compliance monitoring/tracking, reporting and performance metrics/scorecards and assessed compliance risks for event management system under the Corporate Integrity Agreement

• 

  Syneos Health

  Jul 2019 - Apr 2021

  Project Manager

  Marketing Operations PM with primary areas of focus ranging from Conventions Management and Coordination, Contract Management lifecycle and Task Order Management to building detailed plans, including activities, timelines, ownership, cross-functional dependencies, and risk mitigation planning for assigned project(s).Client: Seqirus Inc.

• 

  Sanofi

  May 2021 - now

  • Associate Director - Portfolio Operations & Launch Management

    Feb 2023 - now

  • Senior Project Manager

    May 2021 - Jan 2023