Software Quality Assurance Manager
Core
Independent quality assurance, validation governance, and compliance oversight for eQMS, a GxP-regulated custom-built enterprise application.
Role type
Senior IC Software Quality Assurance Manager (GxP/Validation)
Builds
eQMS platform (custom-built enterprise application for Pharma business line)
Domain
Life Sciences / Pharma / GxP Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance, GAMP5, Computer System Validation (CSV), test automation strategy, CI/CD integration, risk-based validation, SDLC quality controls, change management, audit readiness
Preferred skills
Test orchestration platforms, UI/API automation, DevOps practices, software engineering principles, continuous improvement mindset
Technologies
CI/CD pipelines, test automation frameworks, version control
Responsibilities
Define and enforce quality gates across SDLC phases; Review and approve key documentation (test plans, protocols, release candidates); Oversee Computer System Validation activities (IQ/OQ/PQ); Provide formal QA release approval for production deployments; Drive test automation strategy and integration into CI/CD; Support audits and regulatory inspections
Seniority
Senior, hands-on IC with strategic oversight
