Venkat Cherukuri

About Venkat Cherukuri

Accomplished technologist with over 20 years of experience in regulatory compliance, Data Integrity Governance, project/program management, enterprise application implementations, process improvement, change management, quality assurance, and expertise in developing strategic solutions and ensuring tactical implementation of those strategies for globally diverse and inclusive organizations with global Fortune 500 Pharma, Biotech, Medical Device, & Healthcare Life Sciences companies. I lead with a passion for advancing digital capabilities that support the mission to discover, manufacture, and deliver lifesaving medicines to patients- Proven management skills, Consistently improve team communications, achieve team consensus, and build strong client/sponsor relationships, including the ability to prioritize, multitask, and meet deadlines-Areas of expertise include GXP regulations, Computer System Validation, 21 CFR Part 11, FDA Consent Decree, Warning Letter and Corporate Integrity Agreement, Sarbanes-Oxley (SOX), Project Management, System Development, and Auditing-Provide subject matter expertise to the Client’s business units in Pharma, Biotech, Consumer, and Medical Devices developing or acquiring innovative products and solutions-Experience in manufacturing execution systems (MES) interfaces, recipe review, process analytical technologies (PAT), and data historians (OSI PI) used in the manufacture of drug substances and drug products-Experience in multiple global implementations and qualification of ERP systems (SAP/JDE/OPM),(OTC, IM, PM, WM, SD, MM, PP & CRM modules) Inventory management systems, labeling systems, expertise spans across R&D, manufacturing, quality, supply chain, and clinical systems(CTMS/eTMF) COMPASS.Deep business & knowledge of enterprise lab systems such as Electronic Lab Notebooks (ELN), Lab Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), Product Lifecycle Management (PLM), Life Sciences Cloud Utility, Clinical Aggregation Layer, LSH Life Science Data Hub, CDA,(CAPA) management, ETQ, and TrackWise and Model N-Rapidly Improving Operational efficiency, exceptional problem-solving skills, and A team builder hires, trains, and develops talent, which results in the development of several Quality leads.Specialties: GAMP, Risk/Change Management, Gap Analysis, Remediation, FMEA, FDA 21 CFR Part 11, CFR 820, 21 CFR 210 & 211 GMP, 21 CFR 50 and 56 GCP and 21 CFR 58 GLP, MHRA, HPRA, Annex 11 and SOX/ISO, BA, Security, PHI, PI, Safe Harbor, MA 201, Data Privacy, Agile Scrum and RWE/RWD.

Experience

1. Associate Director, Quality Information Systems Management

   Vertex Pharmaceuticals

   May 2023 — Present · Boston, MA, US

   A trusted Quality partner with strong leadership skills and a track record of motivating teams and modeling the change expected of others-Proven management skills, including prioritizing, multitasking, and meeting deadlines-Areas of expertise include GXP regulations, Computer System Validation, 21 CFR Part 11, Security, identity management, Data Integrity, Project Management, System Development, and Auditing/compliance with internal controls and GxP requirements-Provide subject matter expertise to the Client\'s business units.

Education

• Monroe University

  Master of Science in Health Care Administration / Management MBA,

  2021

• California University

  Masters of Science in Computer Science, MS in Computer Science

• University of Madras

  Bachelor of Engineering (B.E.), Mechanical Engineering

  1996 — 2000