Senior Manager, Software Quality Engineering – V&V
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Job Description
Senior Manager leading software quality engineering and validation for Clario’s eCOA clinical technology. Driving testing standards, automation, AI, compliance, and global QA operations.
Responsibilities:
- Lead strategic initiatives within eCOA Service Delivery Quality Engineering
- Establish and implement process and technology standards for all eCOA projects and deliverables
- Manage offshore testing vendors, resources, and capacity planning
- Redefine system validation processes using industry best practices, test automation, and AI
- Drive improvements in validation capabilities through test automation and AI tools
- Establish software quality standards across study configuration, documentation, development, testing, and maintenance
- Manage day-to-day QA testing department operations, direct reports, and offshore teams
- Approve timesheets, review training records, and resolve project progress issues and conflicts
- Improve department efficiency through best practices, test automation, and software quality metrics
- Partner with HR on hiring, development, and performance management
- Reallocate SQE resources within squad teams
- Build departmental strategies and tactical plans aligned with corporate goals
- Develop, maintain, and report departmental KPIs
- Supervise Project SQE Managers and resolve technical challenges
- Hire, train, and manage SQE personnel
- Maintain Service Delivery QA standard operating procedures
- Attend project review meetings
- Ensure timely, compliant delivery of software validation efforts
- Advise project teams on testing approaches, best practices, scheduling, effort estimates, and regulatory expectations
- Monitor testing progress, review issues, and develop mitigation plans for at-risk projects
- Administer JIRA, GIT, and Jama
- Respond to audit observations and implement CAPAs
- Review project status and resolve risks to meet target dates
- Implement new tools and processes
- Guide individual development and growth plans
- Manage strategic services and technology partnerships, including offshore QA/validation resources
Requirements:
- BS, BA or equivalent in an Information Technology or related field required
- Minimum 12 years Global Clinical Operations experience with a focus on the clinical trial phases and associated lifecycles OR minimum 12 years' experience in Software Delivery Operation (Client Operations)
- Minimum 10 years of software validation experience, preferably in a regulated environment
- Proven experience in Test Automation and AI is a strong plus
- Experience managing offshore testing vendors, resources, and capacity planning
- Experience with software quality standards, system validation, testing, and maintenance
- Experience with JIRA, GIT, and Jama
- Experience with KPIs, software quality metrics, and regulatory expectations
- Experience hiring, training, supervising, and managing SQE personnel
Benefits:
- Competitive compensation and incentives
- Private health insurance
- Pension
- Life insurance
- Engaging employee programs
- Modern technology for remote collaboration
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