SmartSolve (IQVIA) Product Consultant

Job Description: SmartSolve (IQVIA) Product Consultant

Job Title: SmartSolve (IQVIA) Product Consultant

Experience: 8 10 Years

Work Location: Chennai, Pune, Bangalore

Domain: Life Sciences / Quality Management Systems (eQMS)

contract role

Job Summary

We are seeking an experienced SmartSolve (IQVIA) Product Consultant with strong hands-on expertise in electronic Quality Management Systems (eQMS) within regulated life sciences environments. The candidate will be responsible for assessing SmartSolve capabilities against business and quality requirements, evaluating product fit and gaps, supporting vendor evaluations, and contributing to implementation, licensing, and support cost assessments.

Key Responsibilities

• Participate in discovery sessions and current-state assessment workshops to gather and validate eQMS requirements.
• Assess SmartSolve (IQVIA) capabilities across 13 quality domains and document out-of-the-box functionality, configuration options, gaps, customization requirements, and workarounds.
• Evaluate SmartSolve against functional and non-functional requirements using weighted scoring methodologies.
• Support eQMS product evaluation, RFP preparation, vendor response analysis, scripted demonstrations, and reference checks.
• Assess SmartSolve deployment options, technical architecture, integration approaches, reporting capabilities, and data migration considerations.
• Provide ballpark licensing, implementation, and Application Management Services (AMS) cost estimates.
• Prepare evaluation documentation, scoring summaries, executive presentations, and final product recommendations.
• Ensure requirements traceability and alignment with Computer System Validation (CSV), Computer Software Assurance (CSA), and applicable GxP requirements.
• Consider cybersecurity, data privacy, licensing, and operational support factors during product evaluation.

Required Technical Skills

• Strong hands-on experience with SmartSolve (IQVIA) eQMS.
• Expertise in core quality management modules, including:
• Document Control
• Training Management
• Deviations and Nonconformance
• Corrective and Preventive Actions (CAPA)
• Change Control
• Audits
• Supplier Quality
• Complaints Management
• Quality Events
• Management Review and Reporting
• Understanding of SmartSolve data models, configurable workflows, platform architecture, and deployment options.
• Experience evaluating integrations with ERP, MES, LIMS, PLM, EDMS, and LMS systems.
• Knowledge of reporting, analytics, data migration, and licensing models.
• Working knowledge of regulatory and quality standards, including 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, EU MDR, ISO 13485, and GxP.
• Experience with eQMS product evaluation, requirements mapping, fit-gap analysis, weighted scoring, and RFP assessments.
• Familiarity with CSV/CSA and validation-driven environments.
• Awareness of cybersecurity and data privacy standards, including SOC 2, ISO 27001, and GDPR. Experience Requirements
• 8 10 years of experience in Life Sciences quality systems or eQMS consulting.
• At least 4 years of hands-on SmartSolve (IQVIA) experience in implementation, configuration, support, or product evaluation engagements.
• Experience in client-facing consulting, product assessments, and quality process harmonization.

Good-to-Have Skills

• Exposure to Veeva Vault QMS and ETQ Reliance.
• Experience in biotechnology, Contract Development and Manufacturing Organizations (CDMOs), or medical device quality operations.
• Knowledge of regulated manufacturing environments.
• Strong workshop facilitation, documentation, stakeholder management, and executive presentation skills.

Key Competencies

• SmartSolve product expertise and functional assessment.
• eQMS requirements analysis and fit-gap assessment.
• Product evaluation and vendor scoring.
• Regulatory compliance and quality systems knowledge.
• Cost estimation and licensing assessment.
• Client communication and executive-level reporting. send resumes to manohar@galaxyitech.com