Greymatter Innovationz
IQVIA SmartSolve Techno-Functional Consultant – QMS
Greymatter Innovationz, Trenton, New Jersey, United States
IQVIA SmartSolve Techno-Functional Consultant – QMS
Greymatter Innovationz
Location: NJ/ CT/ PA
Experience: 5 to 10 Years
Job Summary We are seeking an experienced IQVIA SmartSolve Techno-Functional Consultant*with strong expertise in Quality Management Systems (QMS). The role involves configuring, implementing, supporting, and optimizing IQVIA SmartSolve solutions while ensuring compliance with global regulatory standards. The consultant will act as a bridge between business stakeholders and technical teams across global engagements.
Key Responsibilities Functional Responsibilities
Lead and support IQVIA SmartSolve QMS implementations and enhancements
Gather, analyze, and document business requirements for QMS processes
Configure SmartSolve modules such as Document Management (DMS), Training Management, CAPA, Change Control, Deviations, Audits & Inspections
Ensure compliance with GxP, FDA 21 CFR Part 11, ISO 13485, ISO 9001 and other global regulations
Conduct user training, workshops, and UAT support
Prepare functional specifications, validation documents, and SOPs
Technical Responsibilities
Perform SmartSolve configuration and basic customization
Support integrations with other enterprise systems (e.g., ERP, LIMS, PLM)
Work with technical teams on data migration, system upgrades, and issue resolution
Troubleshoot application issues and provide production support
Collaboration & Stakeholder Management
Act as primary point of contact for business users and clients
Collaborate with global teams across Pan India and USA
Provide status updates, risk identification, and mitigation plans
Required Skills & Qualifications Mandatory Skills
5–10 years of experience in QMS implementations
3+ years of hands‑on experience with IQVIA SmartSolve
Strong understanding of Life Sciences / Pharma / Medical Devices domain
Excellent knowledge of GxP regulations and compliance requirements
Experience in techno‑functional role (configuration + business analysis)
Technical Skills
SmartSolve configuration and administration
Data migration and reporting
Integration understanding (REST/SOAP APIs – good to have)
Soft Skills
Strong communication and stakeholder management skills
Ability to work independently and in global teams
Excellent documentation and presentation skills
Nice to Have
Experience working with US and global clients
Knowledge of CSV (Computer System Validation)
Exposure to other QMS tools (TrackWise, Veeva QMS, MasterControl)
Education
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field
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Location: NJ/ CT/ PA
Experience: 5 to 10 Years
Job Summary We are seeking an experienced IQVIA SmartSolve Techno-Functional Consultant*with strong expertise in Quality Management Systems (QMS). The role involves configuring, implementing, supporting, and optimizing IQVIA SmartSolve solutions while ensuring compliance with global regulatory standards. The consultant will act as a bridge between business stakeholders and technical teams across global engagements.
Key Responsibilities Functional Responsibilities
Lead and support IQVIA SmartSolve QMS implementations and enhancements
Gather, analyze, and document business requirements for QMS processes
Configure SmartSolve modules such as Document Management (DMS), Training Management, CAPA, Change Control, Deviations, Audits & Inspections
Ensure compliance with GxP, FDA 21 CFR Part 11, ISO 13485, ISO 9001 and other global regulations
Conduct user training, workshops, and UAT support
Prepare functional specifications, validation documents, and SOPs
Technical Responsibilities
Perform SmartSolve configuration and basic customization
Support integrations with other enterprise systems (e.g., ERP, LIMS, PLM)
Work with technical teams on data migration, system upgrades, and issue resolution
Troubleshoot application issues and provide production support
Collaboration & Stakeholder Management
Act as primary point of contact for business users and clients
Collaborate with global teams across Pan India and USA
Provide status updates, risk identification, and mitigation plans
Required Skills & Qualifications Mandatory Skills
5–10 years of experience in QMS implementations
3+ years of hands‑on experience with IQVIA SmartSolve
Strong understanding of Life Sciences / Pharma / Medical Devices domain
Excellent knowledge of GxP regulations and compliance requirements
Experience in techno‑functional role (configuration + business analysis)
Technical Skills
SmartSolve configuration and administration
Data migration and reporting
Integration understanding (REST/SOAP APIs – good to have)
Soft Skills
Strong communication and stakeholder management skills
Ability to work independently and in global teams
Excellent documentation and presentation skills
Nice to Have
Experience working with US and global clients
Knowledge of CSV (Computer System Validation)
Exposure to other QMS tools (TrackWise, Veeva QMS, MasterControl)
Education
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, or related field
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