Technical Lead- IQVIA SmartSolve QMS -Remote

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.