Computer System Assurance Consultant – PV, Clinical, Regulatory Affairs
ilb Consulting Services
contract
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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
Requirements
- 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.
Benefits
- Competitive C2C or W2
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP systemsCSVCSA principlesSDLC processesvalidation documentationValidation PlansRisk AssessmentsTraceability MatricesValidation Summary Reportschange control
Soft skills
strong communication skillsindependent workability to work in a fast-paced environmentinterpersonal skills