Senior QA Lead – CSV

Hi,

Hope you  are doing well,

This is Aakash from HRize. We have an opportunity Senior QA Lead – CSV role. Kindly respond to this requirement with your  resume, contact and current location info to speed up the interview process.
Senior QA Lead – CSV
Client: Confidential – Pharma Company
Employment Type: Long-Term Contract
Location: 100% Remote
Work Authorization: USC Only
Additional Requirements: Valid U.S. Driver’s License + LinkedIn Profile

Position Overview
We are seeking a Senior QA Lead – AI & Platform Validation to lead Computer System Validation (CSV) activities for an AI-driven enterprise application and its supporting Google Cloud Platform (GCP) environments.

The ideal candidate will have strong experience in GxP-regulated environments, with hands-on expertise authoring and executing validation protocols, documenting objective evidence, managing discrepancies through closure, and preparing complete validation records that demonstrate systems are fit for their intended use.

Key Responsibilities
Test Case Authoring
Develop detailed, risk-based test cases and validation protocols.
Author and execute IQ/OQ/PQ protocols for enterprise applications and infrastructure.
Ensure test coverage aligns with system requirements, intended use, and applicable quality standards.
Test Execution & Documentation
Execute validation test cases and accurately document results.
Capture contemporaneous, objective evidence in accordance with Good Documentation Practices (GDP).
Clearly document pass/fail determinations, deviations, and supporting evidence.
Prepare and maintain validation documentation and Validation Summary Reports (VSRs).
AI & Agentic Functionality Validation
Validate AI-driven and agentic application functionality within a regulated environment.
Develop test approaches for AI workflows, outputs, integrations, and system behavior.
Assess functionality against predefined requirements and intended use.
Environment & Infrastructure Qualification
Support qualification and validation of application environments and supporting Google Cloud Platform (GCP) infrastructure.
Ensure infrastructure and environments meet applicable validation and quality requirements.
Coordinate with technical teams to resolve environment-related validation issues.
Quality System & Governance
Manage test discrepancies, deviations, and defects from identification through documented closure.
Support investigations, root-cause analysis, corrective actions, and resolution activities.
Maintain complete and inspection-ready validation records.
Support internal audits and regulatory inspections, including direct interaction with auditors and investigators.
Ensure all validation activities comply with applicable GxP, CSV, and quality-system requirements.
Required Qualifications
7+ years of experience in Computer System Validation (CSV) or Software Quality Assurance within a GxP-regulated environment.
Proven experience authoring and executing IQ/OQ/PQ protocols.
Experience preparing Validation Summary Reports (VSRs) for enterprise systems.
Strong hands-on knowledge of Good Documentation Practices (GDP) and contemporaneous evidence capture.
Demonstrated experience managing discrepancies and deviations through investigation, resolution, and documented closure.
Experience supporting internal audits and regulatory inspections, including direct interaction with auditors or investigators.
Experience with validation of enterprise applications and supporting infrastructure.
Exposure to AI/ML or agentic applications and their validation is highly desirable.
Experience with Google Cloud Platform (GCP) environments is strongly preferred.
Exceptional written and verbal communication skills.
Outstanding attention to detail and documentation precision; validation records must be clear, objective, complete, and inspection-ready.
Ideal Candidate
The strongest candidate will be a hands-on QA/CSV professional, not simply a QA manager. They should be comfortable owning the complete validation lifecycle—from protocol authoring and test execution through evidence collection, discrepancy management, final reporting, and audit readiness—within a highly regulated pharmaceutical environment.