Senior Manager, Software Quality Engineering (V&V)
Core
Leading the development and execution of strategic initiatives for eCOA Service Delivery Quality Engineering, establishing process and technology standards to ensure accurate and dependable products.
Role type
Senior Manager, Software Quality Engineering (V&V)
Builds
eCOA study configuration life cycle, documentation, development methods, testing, and maintenance deliverables
Domain
Clinical trial software validation and quality engineering
Deliverable
production ML models
Required skills
Software validation, test automation, AI concepts, offshore vendor management, resource planning, process improvement, KPI reporting, team leadership, regulatory compliance
Preferred skills
Test automation, AI tools, industry best practices
Technologies
JIRA, GIT, Jama
Responsibilities
Establish and implement process and technology standards for eCOA projects; manage offshore testing vendors and resource capacity; redefine validation processes leveraging test automation and AI; manage day-to-day operations of the QA testing department including direct reports; supervise Project SQE Managers; develop and maintain SOPs; monitor project testing progress and mitigate risks; administer departmental systems and tools; respond to audit observations and implement CAPAs; build departmental strategies aligned to corporate goals.
Seniority
Senior, hands-on IC with management responsibilities