CSA Consultant for PV, Clinical & Regulatory Systems

Verista, Inc.; King of Prussia (PA); Hybrid; USD 70,000 - 118,000; Full time

Benefits offered by this job

Health Savings Account

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Employee Referral Program

Bereavement Leave

Job summary

Verista, Inc. is seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance across Pharmacovigilance, Clinical, and Regulatory Affairs systems.

This role collaborates with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. You will provide CSA/CSV SME guidance, participate in validation activities, review lifecycle documentation, and support change

Qualifications

• 5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains.
• Strong understanding of CSA, CSV, and SDLC processes; experience authoring or reviewing validation documents.

Responsibilities

• Provide CSA/CSV SME guidance across PV, Clinical, and Regulatory Affairs platforms.
• Support validation activities including validation plans, risk assessments, traceability matrices, and validation summaries.
• Review lifecycle documentation (URS, specifications, test plans, test summaries) per ALCOA+ and GDP.
• Oversee validation readiness and ensure prerequisites are met before testing.
• Support change control, configuration management, and release activities.

Skills

CSA principles

CSV

SDLC

GxP regulations

communication

Job description

Verista, Inc. is seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance across Pharmacovigilance, Clinical, and Regulatory Affairs systems.

This role collaborates with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures. You will provide CSA/CSV SME guidance, participate in validation activities, review lifecycle documentation, and support change