Senior QA Lead - AI & Platform Validation (GxP / Computer System Validation)
Contract Position - 12months+
Rate:$60.00-$62.00 per hour on a W2 basis
NO SPONSORSHIP or C2C help in any form
REMOTE ROLE - EST Preferred

Overview
Help a large pharma organization keep a high-impact, AI-driven enterprise application in an inspection-ready validated state. In this role, you'll own end-to-end Computer System Validation (CSV) across the application and its supporting Google Cloud environments--authoring clear, audit-ready test cases, executing protocols with impeccable documentation, driving discrepancies to closure, and producing the complete validation record that proves the system is fit for intended use.
You'll partner closely with Business Analysts and Quality leadership to define measurable acceptance criteria (including for probabilistic/AI outputs), validate human-in-the-loop controls, and ensure every requirement is traceable from specification through executed evidence. The work moves fast in sprints, with strong collaboration in Jira and Confluence, and it's ideal for a QA leader who thrives in ambiguity and delivers precision under pressure.

• Computer System Validation (CSV) / Software QA in GxP environments with strong pharma or regulated industry experience
• Expert-level capability authoring and executing IQ/OQ/PQ protocols and producing validation documentation (including validation summary records)
• Strong test case authoring skills: clear preconditions, discrete steps, explicit expected results, and defined objective evidence
• Requirements Traceability Matrix ownership and maintenance (requirement ? spec ? test case ? executed evidence ? result)
• Good Documentation Practices (GDP) and contemporaneous evidence capture (e.g., screenshots, logs, reports, queries)
• Proven experience managing test discrepancies/deviations through investigation to documented closure
• Experience supporting internal audits and/or regulatory inspections, including presenting validation approach and evidence
• Ability to validate systems where outputs may be "right most of the time," including defining pass/fail acceptance criteria with stakeholders
• Strong cross-functional collaboration and influence without authority
• Authorization to work in the United States without current or future sponsorship

• Validation experience specific to AI/agentic functionality, including:
  • Golden dataset and evaluation harness qualification under change control
  • Testing of confidence thresholds and defined behavior below thresholds
  • Human-in-the-loop workflow validation and audit trail verification
  • Traceability to model version, prompt/config version, and data snapshot
  • Revalidation strategy for model/version changes and regression evaluation
• Qualification of cloud infrastructure and environment representativeness across dev/test/prod
• Experience reviewing/approving CI/CD-generated automated test evidence and qualifying automation tooling used as validation evidence
• Familiarity with Google Cloud environment qualification and configuration management / infrastructure-as-code verification

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field
• 7+ years of computer system validation or software quality assurance experience in a GxP-regulated environment

• Remote role; ability to work effectively with teams operating on Eastern Time (CST/EST preferred)
• Comfortable working in a fast-paced, sprint-based delivery model using Jira and Confluence
• Must be proactive, resilient, resourceful, and effective in ambiguity--this role requires ownership and follow-through