Program Quality Manager

Programs/Projects: Legal & Compliance, People & Organization (LMS/Workday/Peripherals), Travel Management, Site Migration

• Lead, coordinate, and manage IT quality and validation efforts for Cloud/SaaS/On-Prem migration or replacement projects, aligning with company Information Security and SDLC SOP/Quality standards, as part of TSA exit strategy for Corporate Functions
• Develop a comprehensive Quality/Validation strategy outlining actions, deliverables, responsibilities, and procedures to guide individual project execution
• Partner with Program/Project Managers to lead project teams from a quality perspective, defending quality approaches, resolving conflicts, and negotiating solutions
• Responsible for ensuring the delivery of mandatory TSA exit deliverables for successful TSA exit of each project bundle
• Verify the completeness and accuracy of qualification/validation activities through detailed Qualification/Validation reports
• Collaborate effectively with all levels of management and suppliers to ensure a consistent supply of high-quality products and services

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Consultant

Programs/Projects: Patient Safety Services, Identity and Access Management Transformation, Data Leakage and Azure Information Protection

• Provide strategic guidance for validating (Risk-Based Validation Approach) GxP systems (Cloud SaaS/IaaS/PaaS), Business applications- Patient Safety and various tools
• Responsible for contributing to the design and implementation of the risk-based audit and quality assurance oversight strategy covering the CSV regulated activities
• Supporting delivery of GxP critical Business processes for IT applications and Cloud solutions (SaaS/IaaS and PaaS)
• Coordinating with cross-functional teams, building strong relationships, solving problems, resolving conflicts, and communicating effectively with all stakeholders
• Provide guidance to implement Quality by design by recommending and verifying appropriate IT controls
• Experience includes end-to-end Computer System Validation, Software Quality Assurance, Project Management, Change Management and Liaison with cross-functional divisions (Information Security, Data Privacy) and Software development lifecycle models

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Manager / Project Manager /QA / Compliance / Validation Consultant

Projects: SQA Operating model and System Lifecycle, Computerized Lab systems remediation, SOP implementation and effectiveness check, Designing System Lifecycle and Software Quality assurance operating model

• Quality remediation for Computerized lab systems
• Monitor quality control and oversight processes (quality review checks, independent verification & validation
• Create a training plan for SQA methodology and SLC process and compile training materials as required

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Other experience include CSV Consultant and Quality Consultant