Senior QA Lead - AI and Platform Validation

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.

Responsibilities

• Own end-to-end Computer System Validation (CSV) for an AI-driven enterprise application and its supporting Google Cloud environments.
• Author clear, audit-ready test cases and execute IQ/OQ/PQ protocols with impeccable documentation.
• Drive discrepancies and deviations to closure with thorough investigation and documentation.
• Produce complete validation records to demonstrate the system is fit for intended use.
• Partner with Business Analysts and Quality leadership to define measurable acceptance criteria, including for probabilistic/AI outputs.
• Validate human-in-the-loop controls and ensure traceability of every requirement from specification through executed evidence.
• Maintain and own the Requirements Traceability Matrix (requirement → spec → test case → executed evidence → result).
• Support internal audits and regulatory inspections, including presenting validation approach and evidence.
• Collaborate in a fast-paced, sprint-based environment using Jira and Confluence.

Requirements

• Computer System Validation (CSV) / Software QA experience in GxP environments, preferably in pharma or regulated industries.
• Expert-level capability in 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.
• Proficiency in Good Documentation Practices (GDP) and contemporaneous evidence capture (e.g., screenshots, logs, reports, queries).
• Experience managing test discrepancies/deviations through investigation to documented closure.
• Ability to validate systems with probabilistic outputs, 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.
• 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.
• Proactive, resilient, resourceful, and effective in ambiguity—this role requires ownership and follow-through.

Nice to Have Skills

• 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.

Qualifications

• 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.

Pay

$60.00-$62.00 per hour on a W2 basis.

Schedule

12-month+ contract position. Remote role with EST preferred.