GxP CSA Consultant: Validation & Compliance Leader

United Pharma; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

United Pharma is seeking an experienced Computer System Assurance (CSA) Consultant to support GxP-regulated systems across Pharmacovigilance, Clinical and Regulatory Affairs. You will ensure system compliance during implementation, upgrades, integrations and operations, collaborating with Quality, IT and business teams to uphold data integrity and regulatory alignment.

The role focuses on risk-based CSA strategies, documentation reviews, lifecycle management, and audits/inspections to

Qualifications

• 5–8 years of hands-on experience supporting GxP systems in regulated areas.
• Strong understanding of CSA, CSV and SDLC processes.
• Knowledge of FDA, EMA, ICH regulations and data integrity principles.
• Familiarity with ALCOA+ and GxP documentation practices.
• Experience with change control and system lifecycle management.

Responsibilities

• Provide CSA/CSV expertise for GxP applications across Pharmacovigilance, Clinical, and Regulatory Affairs.
• Support system implementations, upgrades, enhancements, integrations and data migrations from a compliance perspective.
• Prepare and review validation docs including risk assessments, validation plans, traceability matrices, and summaries.
• Review requirements, specs, test protocols and results for GxP compliance.
• Apply risk-based CSA methodologies to determine testing/documentation needs.
• Advance change control, release management, configuration updates, and system lifecycle activities.
• Conduct periodic compliance assessments, validation health checks, user access reviews and audit trails.
• Assess deviations, incidents, CAPAs and system issues with appropriate investigations/remediation.
• Collaborate with Quality, IT and process owners to maintain validated GxP state.
• Support audits, inspections and continuous improvement related to computerized system compliance.

Job description

United Pharma is seeking an experienced Computer System Assurance (CSA) Consultant to support GxP-regulated systems across Pharmacovigilance, Clinical and Regulatory Affairs. You will ensure system compliance during implementation, upgrades, integrations and operations, collaborating with Quality, IT and business teams to uphold data integrity and regulatory alignment.

The role focuses on risk-based CSA strategies, documentation reviews, lifecycle management, and audits/inspections to