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Senior CSV & Validation Lead - Regulated Systems Expert

Job in Chicago, Cook County, Illinois, 60290, USA
Listing for: OnShore Technology Group
Full Time position
Listed on 2026-07-27
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Salary/Wage Range or Industry Benchmark: 120000 - 170000 USD Yearly USD 120000.00 170000.00 YEAR
Job Description & How to Apply Below

OnShore Technology Group in Chicago, IL, seeks a Sr. Validation Lead to oversee CSV activities for designated computerized system implementations in GMP/GLP/GCP environments.

You will develop and review validation test protocols, coordinate with SMEs, and ensure all deliverables align with FDA 21 CFR Part 11, ISPE GAMP 5, and related regulations. The ideal candidate has 10+ years in software quality assurance within life sciences, strong leadership, and proven ability to manage multiple CSV

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Position Requirements
10+ Years work experience
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