GxP Validation Lead

Company Overview

Req ID: 396922

NTT DATA strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a candidate to join our team in Plano, Texas (US-TX), United States (US).

• GxP and Validation Strategy:
• Develop and maintain the overall Computer System Validation / Computer Software Assurance strategy for the NetSuite implementation and associated applications.
• Define the GxP impact, intended use, validation scope, system boundaries, criticality, and validation approach for each applicable computerized system.
• Facilitate or lead Computer Software Risk Assessments (CSRA) and other system risk assessments.
• Apply a documented, risk-based approach to determine the appropriate level of validation rigor and testing.
• Establish clear validation boundaries between NetSuite, QCBD or other Quality Management Systems, integrations, interfaces, reports, workflows, and supporting applications.
• Advise project leadership on validation-related go-live readiness and compliance dependencies.
• 21 CFR Part 11 and Regulatory Compliance:
• Assess applicable system functionality against 21 CFR Part 11 requirements for electronic records and electronic signatures.
• Evaluate controls including:
• user access and security;
• role-based authorization;
• electronic signatures;
• audit trails;
• record retention;
• data integrity;
• system-generated records;
• change control;
• backup and recovery;
• record availability and retrieval.
• Ensure validation activities remain aligned with applicable predicate-rule requirements and company Quality Management System procedures.
• Provide guidance on FDA expectations for computerized systems and risk-based Computer Software Assurance.
• Support alignment with applicable medical-device Quality Management System Regulation (QMSR) requirements where relevant.
• Validation Planning and Documentation:
• Develop or review the Computer System Validation Plan / Validation Strategy.
• Define the required validation deliverables based on system risk and intended use.
• Lead or provide oversight for preparation and approval of validation documentation, which may include:
• GxP impact assessments;
• CSRA / risk assessments;
• validation plans;
• user and functional requirements;
• configuration specifications;
• requirements traceability matrices;
• test strategies;
• IQ/OQ/PQ or equivalent risk-based verification protocols;
• test scripts and test evidence;
• deviation and defect assessments;
• validation summary reports;
• release and change-impact assessments.
• Ensure validation documentation is clear, traceable, reviewable, and suitable for internal and external audit purposes.
• Ensure critical requirements are traceable from intended use and risk through testing and final approval.
• NetSuite and SaaS Validation:
• Define a practical validation approach for Oracle NetSuite as a cloud-based SaaS application.
• Assess configured processes, workflows, roles, reports, integrations, scripts, custom fields, electronic approvals, and other GxP-relevant functionality.
• Determine which NetSuite functionality is GxP critical and which functionality can be managed under standard business controls.
• Establish an appropriate strategy for periodic NetSuite releases and application updates.
• Review vendor release information and perform documented change-impact assessments.
• Determine when regression testing or targeted revalidation is required following cloud releases or configuration changes.
• Support validation of integrations between NetSuite and QMS, manufacturing, labeling, tax, banking, reporting, and other applications where those interfaces affect GxP records or processes.
• Data Integrity and Migration:
• Assess data migration activities for GxP impact and validation requirements.
• Define validation expectations for migration of regulated master data, historical records, transactional data, and reference data.
• Ensure appropriate reconciliation, completeness checks, accuracy checks, and migration evidence are maintained.
• Advise on data-retention and archival strategies for legacy GxP records that will not be migrated into NetSuite.
• Quality System Integration:
• Work with Quality and business stakeholders to determine the appropriate system of record for regulated processes and records.
• Ensure NetSuite and QMS responsibilities are clearly delineated.
• Help determine which processes should remain within the existing QMS and which may appropriately be enabled in NetSuite.
• Support development or revision of SOPs, work instructions, validation procedures, and system-governance processes.
• Ensure validation deliverables are routed through the organization's approved document-control and Quality Management System processes.
• Testing and Execution Oversight:
• Provide oversight and guidance to business SMEs executing validation protocols and user acceptance testing.
• Ensure tests are risk-based and focused on critical business and compliance controls.
• Review test evidence for completeness and adequacy.
• Support investigation and disposition of validation deviations and defects.
• Ensure unresolved issues are appropriately risk assessed before production release.
• Audit and Inspection Readiness:
• Maintain validation documentation in an inspection-ready state.
• Support internal Quality audits, customer audits, regulatory inspections, and third-party assessments.
• Explain and defend the validation strategy, risk-based rationale, testing approach, and validation evidence when required.
• Identify validation or compliance gaps and develop pragmatic remediation plans.
• Stakeholder Leadership:
• Serve as the primary GxP / CSV advisor to project leadership.
• Partner with Quality Assurance, Regulatory Affairs, IT, Finance, Supply Chain, Manufacturing, Engineering, and business process owners.
• Translate regulatory requirements into practical system and process controls.
• Facilitate workshops with business users to identify GxP critical processes, records, controls, and risks.
• Provide training and coaching to project teams regarding CSV, Computer Software Assurance, Part 11, data integrity, and validation responsibilities.

Required Qualifications

• 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.
• Ability to communicate complex regulatory and technical requirements clearly to both technical and non-technical stakeholders.
• Strong analytical, facilitation, documentation, and stakeholder-management skills.
• Bachelor's degree in life sciences, engineering, quality, information technology, computer science, or a related discipline, or an equivalent combination of education, training, and relevant professional experience.

Preferred Qualifications

• Experience validating Oracle NetSuite, Oracle Cloud, SAP, or a comparable enterprise ERP platform.
• Experience with regulated medical-device organizations.
• Knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485 principles.
• Familiarity with FDA Computer Software Assurance guidance.
• Knowledge of GAMP 5 and risk-based computerized-system lifecycle practices.
• Experience with Quality Management Systems such as QCBD or comparable electronic QMS platforms.
• Experience validating ERP integrations, master-data conversion, transactional-data migration, reporting, interfaces, and customizations.
• Experience supporting FDA inspections, notified-body audits, customer audits, or internal quality audits.
• Familiarity with manufacturing, supply chain, inventory, product traceability, lot/serial control, quality, and financial processes in a regulated environment.
• Relevant professional certifications in Quality, Regulatory Affairs, Validation, GxP, or Project Management are beneficial but not required.

Core Competencies

• GxP compliance and regulatory interpretation
• Computer System Validation / Computer Software Assurance
• 21 CFR Part 11
• Risk-based validation
• Data integrity
• Validation lifecycle governance
• SaaS and cloud-system validation
• Audit and inspection readiness
• ERP and QMS integration
• Requirements and traceability management
• Change control and release management
• Quality documentation
• Stakeholder facilitation
• Practical problem solving

Success Measures

The successful consultant will:

• Establish an approved and proportionate validation strategy before production deployment;
• Identify GxP-critical functionality and avoid unnecessary validation of non-critical functionality;
• Ensure critical system requirements and controls are traceable to objective validation evidence;
• Establish clear ownership between NetSuite, QMS, legacy systems, and interfaced applications;
• Enable completion of required validation deliverables before go-live;
• Establish a sustainable process for future NetSuite releases, changes, and revalidation; and
• Maintain documentation and system controls in an audit- and inspection-ready state.

About NTT DATA

NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation, and management of applications, infrastructure, and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com

NTT DATA provides a reasonable range of compensation for U.S.-based positions. The starting pay range for this remote role is [$80.57 to $90.51]. This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on a number of factors, including the candidate’s actual work location, relevant experience, technical skills, and other qualifications. This position is eligible for company benefits including participation in medical, dental, and vision insurance, flexible spending or health savings account, and AD&D insurance, employee assistance, participation in a 401k program, and additional voluntary or legally-required benefits

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