Remote cGMP Validation Lead - Oracle EBS QA

Leidos Inc; United States; Remote; USD 59,000 - 107,000; Full time

Job summary

Leidos Inc is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support the SNS program for HHS/ASPR. The role is remote but located in the United States, with preference for candidates near Atlanta, GA.

The candidate will lead validation activities across inventory, warehouse, asset management, and financial processes, ensuring 21 CFR Part 11 compliance.

Qualifications

• 5+ years of experience in computerized-system validation or quality assurance in regulated environments.
• Experience validating cGMP computerized systems in regulated settings.
• Knowledge of 21 CFR Part 11 and validation/change-control principles.
• Experience designing validation plans, protocols, and traceability matrices.
• Experience testing Oracle E-Business Suite (EBS).

Responsibilities

• Lead cGMP validation activities for Oracle EBS applications and enhancements.
• Develop validation plans, traceability, test scripts, and validation evidence.
• Ensure changes comply with cGMP, 21 CFR Part 11, and change-control requirements.
• Integrate validation with Agile development iterations and releases.
• Review requirements, user stories, and validation impact for testability.
• Create and execute test plans for functional, integration, regression, and UAT testing.
• Document test results, defects, deviations, and corrective actions.
• Validate Oracle EBS changes across inventory, warehouse, and financial processes.
• Coordinate validation with analysts, developers, DBAs, and government stakeholders.
• Support release-readiness reviews and provide validation evidence.
• Maintain QA documents per configuration and document-control standards.
• Support audits and requests for validation evidence.
• Participate in Agile planning, refinements, and demos.

Skills

cGMP validation

Oracle EBS

Software QA

Regulated testing

On-call support

Tools

Oracle EBS

Job description

Leidos Inc is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experience to support the SNS program for HHS/ASPR. The role is remote but located in the United States, with preference for candidates near Atlanta, GA.

The candidate will lead validation activities across inventory, warehouse, asset management, and financial processes, ensuring 21 CFR Part 11 compliance.