Job Summary
QA/Test Lead with 7–10 years of experience in software quality assurance, including strong expertise in GxP-regulated environments, functional testing, test automation, API testing, and modern AI-assisted/agentic testing practices.
The Test Lead will own test strategy, planning, execution, quality governance, and coordination across multiple stakeholders while driving the adoption of AI-powered and agentic QA solutions.
The ideal candidate will be hands-on, technically strong, and capable of using AI agents to improve test coverage, accelerate test design and execution, analyze failures, and optimize regression testing while maintaining appropriate human oversight and GxP compliance.
Key Responsibilities
Key Responsibilities
- Own and drive the overall QA and test strategy across functional, integration, system, regression, API, automation, and UAT testing.
- Lead QA activities within GxP-regulated environments, ensuring compliance with validation, quality, documentation, and audit requirements.
- Define test scope, approach, estimates, timelines, entry/exit criteria, and quality metrics.
- Lead the design and implementation of AI-assisted and agentic testing workflows.
- Identify opportunities to use AI agents for:
- Test case and scenario generation
- Requirements analysis and test coverage assessment
- Test data generation
- Automated regression testing
- Failure and defect analysis
- Test prioritization
- Root-cause analysis
- Test reporting and documentation
- Evaluate and govern AI-generated testing artifacts to ensure accuracy, traceability, reliability, and GxP compliance.
- Lead and mentor QA testers and automation engineers.
- Review test cases, automation scripts, test results, defect reports, and validation documentation.
- Coordinate with Business Analysts, Developers, Product Owners, Validation teams, and business stakeholders.
- Establish and monitor QA KPIs, defect trends, test coverage, automation coverage, and release quality.
- Drive defect triage, risk assessment, prioritization, and resolution.
- Develop and maintain automation strategy using Tosca, API automation tools, or similar technologies.
- Oversee API testing using Postman or similar tools.
- Support CI/CD and continuous testing initiatives.
- Ensure complete and compliant GxP documentation, including test protocols, traceability, test evidence, deviation documentation, and test reports.
- Support CSV, audit readiness, inspection readiness, and compliance activities.
- Participate in Agile/Scrum ceremonies and drive continuous quality improvement.
Skill Requirements
Required Skills & Qualifications
- 7–10 years of experience in software QA/testing, with demonstrated test leadership experience.
- Strong knowledge of GxP, CSV, validation, and regulated software environments.
- Strong experience in functional/manual testing and test strategy development.
- Hands-on experience with test automation, preferably Tosca or similar tools.
- Strong API testing experience using Postman or similar tools.
- Proficiency in Java, Python, JavaScript, or another programming/scripting language.
- Experience with JIRA, ALM, or equivalent test/defect management tools.
- Experience leading QA teams and coordinating testing across multiple workstreams.
- Strong understanding of Agile/Scrum and Waterfall methodologies.
- Exposure to Generative AI, AI agents, AI-assisted testing, or autonomous/agentic QA.
- Strong analytical, leadership, communication, and problem-solving skills.
Other Requirements
Preferred Qualifications
- Life Sciences, Pharmaceutical, Healthcare, or other regulated industry experience.
- Experience with AI/ML application testing or LLM evaluation.
- Experience designing agentic workflows for software testing.
- Experience with CI/CD, DevOps, and continuous testing.
- ISTQB or equivalent testing certification.
- Experience with cloud-based applications and modern quality engineering practices.