Cognizant

Compensation

Full Description

Overview: We are seeking a seasoned Technical Delivery Lead to drive the end-to-end implementation and optimization of IQVIA SmartSolve Quality Management System (QMS) solutions. This role requires a deep understanding of quality systems, regulatory compliance, and enterprise integration, with a strong focus on delivering scalable, validated, and business-aligned solutions. Key Responsibilities: • End-to-End Solution Delivery: Lead the full lifecycle of SmartSolve QMS implementations—including system architecture, configuration, customization, and integration with enterprise platforms. • Stakeholder Collaboration: Partner with cross-functional teams (Quality, Compliance, IT, and Business Units) to translate complex business requirements into robust technical solutions. • System Configuration & Security: Oversee system setup activities including user roles and permissions, workflow design, data security controls, and user group management. • Regulatory Compliance: Ensure adherence to GxP standards and 21 CFR Part 11 by implementing comprehensive validation protocols (IQ, OQ, PQ), maintaining audit trails, and supporting documentation. • Form & Report Design: Configure electronic forms, modules, dashboards, and reports to align with operational workflows and regulatory expectations. • Enterprise Integration: Facilitate seamless integration of SmartSolve QMS with external systems such as ERP, LIMS, CRM, and support data migration and transformation efforts. • Team Leadership: Mentor and guide technical teams, promoting best practices in solution design, testing, deployment, and continuous improvement. • Quality Assurance: Lead User Acceptance Testing (UAT), risk assessments, and impact analyses to ensure solutions meet business and compliance needs. • Documentation & SOPs: Develop and maintain detailed technical documentation including configuration specs, validation scripts, SOPs, and change control records. Qualifications: • Minimum 10 years of hands-on experience with Quality Management Systems, including at least 2 years of direct experience with IQVIA SmartSolve. • Proven track record in delivering validated QMS solutions in regulated environments. • Strong understanding of GxP, 21 CFR Part 11, and validation lifecycle methodologies. • Experience with enterprise system integration and data migration strategies. • Excellent communication, leadership, and stakeholder management skills.