Computer System Assurance (CSA) Consultant

Katalyst Healthcares and Life Sciences

Summary:
We are seeking an experienced Computer System Assurance (CSA) Consultant to support GxP compliance activities across Clinical, and Regulatory Affairs systems. This role will work closely with Quality, IT, and business stakeholders to ensure systems are implemented, maintained, and operated in compliance with applicable regulations and internal procedures.

Roles & Responsibilities

Provide CSA / CSV subject matter expertise across PV, Clinical, and Regulatory Affairs platforms
Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
Oversee validation readiness and ensure prerequisites are met prior to formal testing
Support change control, configuration management, and release activities
Partner with Quality, System Owners, and Business Process Owners to ensure ongoing compliance
Provide guidance on CSA-based, risk-driven validation approaches

Education & Experience :

5-8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality and business stakeholders
Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Prior role as a Validation SME, CSA Lead, or Compliance Consultan
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms

Apply

Vacancy posted 4 days ago

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