Experience

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  Dendrite intl.

  May 1999 - Oct 2005

  Sr. certification analyst

  Quality Auditor/Audit Lead-Conducted Internal Process Improvement AuditsCertification Analyst/Leader - Provided leadership and direction for project management ensuring delivery of before project deliverables, problem escalation, liaison efforts between the business and the implementation teams.Quality Assurance Project LeadCollaborated with various functional groups to ensure effective implementation and deployment of WebForce Applications.Quality Assurance Analyst/Validation Analyst - Wrote and executed the test scripts for Software/Data Validation Test Plans for different Pharma clients. Show less

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  Johnson & johnson

  Oct 2005 - Nov 2024

  Compliance manager

  Member of Technical Operations (TO) team providing support to the Bio-statistics and Programming (B&P) for various applicationsBusiness Process Modelling, Enterprise Architecture with ARISData Governance with Master Data Management (MDM) hub and Reference Data Management with CollibraProviding extensive network security support to the clinical trial teams in accordance with our SOPs, Security Policies and FDA regulations.Supporting Process and Systems Harmonization as 3 different R&Ds came togetherSupporting various applications and processes of Biostatistics and Programming groups and managing security for clinical trial dataDesigned internal Continual Process Improvement Audit Program, created tools and templates for the successful and consistent execution of auditsConducted internal process compliance audits for clinical trialsTrained other auditors with new training program, templates and the processReviewed current processes, identified risk areas and created guidelines for different application processes/systems like CRF eSubmission and Database Lock & Top Line Analysis Report Supported introducing new document repository system (ERIS) to R&D group. Provided technical and process support to the usersBeing a member of Technical Operations, helped to enhance the quality in day to day operations, identified discrepancies and addressed the process gaps, and co-authored process documents Migrated eRoom (another document management system in JJPRD) content to MS SharePointCreated new MS SharePoint portals for different groups, and projects Lead MS SharePoint projects for migration, and creation of new portals for various functional groups and projects Show less

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  The janssen pharmaceutical companies of johnson & johnson

  Sept 2024 - now

  Associate director

  Process Excellence in Compliance, and Cross-Functional Compliance Initiatives/Projects.Regulatory Inspection Strategy and Management for Clinical Trial Systems.Continuous improvement programs for Audit Trail, Security Log reviews.