Remote GxP Validation Lead for NetSuite & ERP

NTT DATA; Chicago (IL); On-site; USD 111,000 - 125,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401(k) plan

Flexible spending / Health Savings

AD&D insurance

Job summary

NTT DATA seeks a senior consultant to lead GxP validation and Computer Software Assurance strategies for cloud-based ERP environments like NetSuite. You will drive risk assessments, validation planning, and documentation, ensuring compliance with 21 CFR Part 11 and data integrity across integrated systems.

You will partner with QA, Regulatory Affairs, IT, and business process owners to provide audit-ready validation deliverables and support FDA inspections and regulatory needs.

Qualifications

• 8+ years of experience in GxP computerized system validation, CSV, quality systems, regulatory compliance, or regulated technology implementations.
• 8+ years leading validation strategy for complex enterprise apps, ERP platforms, quality systems, or GxP-relevant systems.
• Strong knowledge of 21 CFR Part 11 and validation principles.
• 8+ years creating and reviewing risk assessments, validation plans, requirements traceability, test protocols, validation evidence, deviations, and validation reports.
• 5+ years in regulated Quality Management System environments and controlled-document environments.
• 5+ years assessing electronic records, signatures, audit trails, access controls, security roles, and data-integrity controls.
• 8+ years supporting SaaS/cloud implementations and upgrades.

Responsibilities

• Develop and maintain the validation strategy for GxP computerized systems in a SaaS environment.
• Lead risk assessments, validation plans, and documentation (IQ/OQ/PQ, traceability matrices, test evidence).
• Ensure data integrity, record retention, and compliant change control.
• Oversee validation of NetSuite integrations with QMS, manufacturing, labeling, and other apps.
• Provide guidance on FDA expectations for CSV and Part 11 compliance.
• Coordinate with QA, Regulatory Affairs, IT, and business process owners.
• Prepare and defend validation deliverables for audits and inspections.

Skills

GxP compliance

Regulatory interpretation

21 CFR Part 11

Risk-based validation

Data integrity

Validation lifecycle governance

SaaS/cloud validation

Audit/inspection readiness

ERP/QMS integration

Requirements & traceability

Change control & release management

Quality documentation

Stakeholder facilitation

Problem solving

Education

Bachelor's degree in life sciences, engineering, quality, information technology, computer science, or related discipline

Tools

NetSuite

QMS (Quality Management System)

Job description

NTT DATA seeks a senior consultant to lead GxP validation and Computer Software Assurance strategies for cloud-based ERP environments like NetSuite. You will drive risk assessments, validation planning, and documentation, ensuring compliance with 21 CFR Part 11 and data integrity across integrated systems.

You will partner with QA, Regulatory Affairs, IT, and business process owners to provide audit-ready validation deliverables and support FDA inspections and regulatory needs.