GxP Validation Lead — ERP & 21 CFR 11 Expert

NTT Data Americas, Inc.; Chicago (IL); Vor Ort; USD 110.000 - 170.000; Vollzeit

Zusammenfassung

NTT DATA seeks a seasoned GxP/CSV consultant to lead validation strategy for ERP and cloud-based systems, ensuring compliance with 21 CFR Part 11 and data-integrity controls.

You will define validation deliverables, lead risk-based testing, coordinate with Quality, Regulatory Affairs, IT, and business process owners, and prepare for inspections and audits. This role requires strong leadership and deep regulatory knowledge.

Qualifikationen

• 8 years of relevant experience in GxP computerized system validation, Computer Software Assurance, quality systems, regulatory compliance, or regulated technology implementation.
• 8 years of demonstrated experience leading validation strategy for complex enterprise applications, ERP platforms, quality systems, manufacturing systems, or other GxP-relevant computerized systems.
• Strong practical knowledge of 21 CFR Part 11 and computerized-system validation principles.
• 8 years of experience developing and reviewing risk assessments, validation plans, requirements, traceability matrices, test protocols, validation evidence, deviations, and validation summary reports.
• 8 years of demonstrated experience applying risk-based validation principles rather than relying solely on prescriptive document-heavy validation approaches.
• 5 years of experience working within a regulated Quality Management System and controlled-document environment.
• 5 years of experience assessing electronic records, electronic signatures, audit trails, access controls, security roles, and data-integrity controls.
• 8 years of experience supporting system implementations, upgrades, releases, configuration changes, or SaaS/cloud applications.

Aufgaben

• Lead validation strategy for complex ERP/QMS systems and cloud-based applications.
• Assess 21 CFR Part 11 compliance and data integrity controls.
• Define validation deliverables based on risk and intended use.
• Support inspections and audits readiness and regulatory alignment.
• Coordinate with cross-functional stakeholders to ensure traceability and control.
• Oversee test strategies, traceability matrices, deviations, and change control.

Kenntnisse

GxP compliance

Regulatory interpretation

21 CFR Part 11

Risk-based validation

Data integrity

Stakeholder management

SaaS/cloud validation

ERP validation

Ausbildung

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

Tools

NetSuite

Oracle Cloud

SAP ERP

QMS platforms

Jobbeschreibung

NTT DATA seeks a seasoned GxP/CSV consultant to lead validation strategy for ERP and cloud-based systems, ensuring compliance with 21 CFR Part 11 and data-integrity controls.

You will define validation deliverables, lead risk-based testing, coordinate with Quality, Regulatory Affairs, IT, and business process owners, and prepare for inspections and audits. This role requires strong leadership and deep regulatory knowledge.