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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.

Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.