Responsibilities
- Lead and maintain the software quality assurance framework for the electronic Quality Management System application.
- Establish and enforce quality checkpoints throughout all phases of the software development lifecycle, including requirements, design, development, testing, and release.
- Evaluate and authorize critical documentation such as user requirements, technical and functional specifications, test strategies, protocols, summary reports, release candidates, and deployment records.
- Ensure full traceability from initial requirements through testing, release, and validation documentation.
- Oversee computer system validation processes, including validation planning, risk-based impact evaluations, installation, operational, and performance qualification activities, and final validation reporting.
- Ensure consistent application of change control processes for functional, technical, and configuration modifications.
- Assess change impact analyses, regression testing plans, deviations, and risk acceptances related to quality.
- Provide official QA sign-off for production deployments.
- Act as the quality assurance representative during audits and regulatory inspections.
- Maintain up-to-date, approved, and inspection-ready software quality and validation records.
- Promote ongoing quality improvements using metrics, trend analysis, audit outcomes, CAPA tracking, and retrospective insights.
- Define and advance the test automation strategy for the eQMS platform.
- Support the adoption of automation-first testing methods, integrating automated tests into CI/CD pipelines and implementing early-stage quality practices across the development lifecycle.
Work Arrangement
Remote (Worldwide)
