Team Lead, Software Quality Engineering (V&V)
Core
Lead and scale the eCOA Software Quality team to ensure high-quality, compliant software delivery in a regulated clinical environment.
Role type
Team Lead, Software Quality Engineering (V&V)
Builds
eCOA (electronic Clinical Outcome Assessment) software solutions for clinical trials
Domain
Life Sciences / Clinical Research / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Software testing methodologies, test case design, defect management, validation documentation, SDLC knowledge, Agile methodologies, test automation strategies, GCP compliance, root cause analysis, vendor management
Preferred skills
ISTQB Advanced Test Analyst or Test Manager certification
Technologies
Automation frameworks, testing tools, validation environments
Responsibilities
Lead and manage day-to-day operations of the SQE team including coordination of onsite and offshore resources; Review project documentation to ensure alignment with quality and regulatory standards; Define overall V&V and test strategies and oversee creation of test cases; Collaborate with Product, Engineering, and Clinical teams to identify risks; Drive root cause analysis for defects and implement CAPA; Establish and improve QA/V&V processes and quality standards; Support internal and external audits; Manage strategic vendor relationships and departmental budget.
Seniority
Senior, hands-on IC with people leadership