CSA Consultant

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

We are looking for an experienced Computer System Assurance (CSA) Consultant to support GxP-regulated systems across Pharmacovigilance, Clinical, and Regulatory Affairs. This role will focus on ensuring system compliance throughout implementation, upgrades, integrations, and ongoing operations. The consultant will collaborate with Quality, IT, and business teams to implement risk-based assurance strategies, maintain data integrity, and ensure alignment with applicable regulatory requirements.

Key Responsibilities:

• Provide CSA/CSV expertise for GxP applications supporting Pharmacovigilance, Clinical, and Regulatory Affairs functions.
• Support system implementations, upgrades, enhancements, integrations, and data migration activities from a compliance perspective.
• Prepare and review validation documentation, including risk assessments, validation plans, traceability matrices, and summary reports.
• Review user requirements, functional specifications, test protocols, and test results to ensure compliance with GxP and ALCOA+ principles.
• Apply risk-based CSA methodologies to determine appropriate testing and documentation requirements.
• Support change control, release management, configuration updates, and system lifecycle activities.
• Conduct periodic compliance assessments, validation health checks, user access reviews, audit trail reviews, and data integrity evaluations.
• Assess deviations, incidents, CAPAs, and system-related issues, ensuring appropriate investigation and remediation.
• Partner with Quality, IT, System Owners, and Business Process Owners to maintain the validated state of GxP systems.
• Support audits, regulatory inspections, and continuous improvement initiatives related to computerized system compliance.

Skills and Qualifications:

• 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or related regulated functions.
• Strong understanding of Computer System Assurance (CSA), Computer System Validation (CSV), and Software Development Life Cycle (SDLC) processes.
• Experience developing, reviewing, and maintaining validation documentation and risk assessments.
• Knowledge of applicable FDA, EMA, and ICH regulations, GxP requirements, and data integrity principles.
• Familiarity with ALCOA+, Good Documentation Practices, change control, and system lifecycle management.
• Experience with enterprise applications supporting clinical, pharmacovigilance, or regulatory operations is preferred.
• Previous experience as a CSA Lead, Validation SME, or Compliance Consultant is an advantage.