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 & Tools
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