CSA Validation Lead for GxP SaaS (Hybrid Raleigh)

Experis (Austria); Raleigh (NC); Hybrid; USD 75,000 - 107,000; Full time

Benefits offered by this job

Medical and Prescription Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Plan

401(k) Plus Match

Weekly Pay

Job summary

ManpowerGroup, the leading global workforce solutions company, is seeking a Validation Specialist in Raleigh, NC. This hybrid role focuses on GxP validation of SaaS and modern software solutions within the R&D IT department, driving CSA-based validation strategy from planning through hypercare.

The candidate will apply GAMP 5 principles, write validation deliverables, and coordinate across technical and regulatory teams to ensure audit-ready documentation and regulatory readiness for submissions.

Qualifications

• Recent CSA experience with US and EU regulations, including US CFR and EU Annex 11.
• Subject matter expertise in CSA and GxP computerized systems, with practical experience applying GAMP 5 principles.
• Ability to write validation deliverables (validation plans, user requirements, testing documentation) and training documentation (User/Admin SOPs as applicable).
• Experience implementing and validating SaaS applications, with familiarity for electronic Instructions For Use and electronic Prescribing Information workflows.

Responsibilities

• Implement GxP computerized systems for R&D IT by applying GAMP 5 principles and CSA best practices to support compliant validation.
• Own validation strategy and execution by reviewing processes and procedures, leading/facilitating meetings, and aligning stakeholders on requirements, testing, and outcomes.
• Write and maintain validation and technical documentation, including validation plans, user requirements, testing documentation, change control support, and training materials.
• Support system implementation activities such as project configuration, user acceptance testing (UAT), and hypercare to maintain a validated state.
• Contribute to regulatory readiness by supporting regulatory intelligence, regulatory submission and deficiency management, and related documentation workflows.

Skills

CSA experience

GxP systems

Regulatory knowledge

UAT testing

Stakeholder collaboration

Job description

ManpowerGroup, the leading global workforce solutions company, is seeking a Validation Specialist in Raleigh, NC. This hybrid role focuses on GxP validation of SaaS and modern software solutions within the R&D IT department, driving CSA-based validation strategy from planning through hypercare.

The candidate will apply GAMP 5 principles, write validation deliverables, and coordinate across technical and regulatory teams to ensure audit-ready documentation and regulatory readiness for submissions.