Senior Manager, Software Quality Engineering
Core
Leading the development and execution of strategic initiatives within eCOA Service Delivery Quality Engineering to ensure quality and timeliness for all deliverables.
Role type
Senior Manager, Software Quality Engineering
Builds
eCOA projects, validation efforts, and testing services for clinical trial phases
Domain
Clinical Operations / Software Delivery / Regulated Environment
Deliverable
production ML models
Required skills
Test automation, AI concepts, software validation, process standardization, offshore vendor management, resource allocation, KPI reporting, team leadership, regulatory compliance, risk mitigation, tool administration (JIRA, GIT, Jama)
Preferred skills
Test automation, AI
Technologies
JIRA, GIT, Jama
Responsibilities
Establish and implement process and technology standards for eCOA projects; manage offshore testing vendors and resource planning; redefine system validation processes leveraging test automation and AI; manage day-to-day operations of the QA testing department including direct reports; improve department efficiency through best practices and metrics analysis; supervise Project SQE Managers; write and maintain Service Delivery QA SOPs; monitor project testing progress and develop mitigation plans; administer departmental systems and tools; respond to audit observations and implement CAPAs.
Seniority
Senior, hands-on IC with management responsibilities