Senior Manager, Software Quality Engineering (V&V)

Overview

In this role, you will lead the Software Quality Engineering efforts for eCOA Service Delivery, establishing standards and driving strategic quality initiatives. You will collaborate with cross-functional teams to ensure timely, high-quality deliverables and strengthen testing coverage across the study lifecycle. You’ll modernize validation practices through automation and AI, while building scalable QA processes that align with corporate goals. This is a hands-on leadership role with impact on customer satisfaction and operational efficiency.

Pay / Benefits

• Competitive compensation
• Private health, pension, and life insurance
• Engaging employee programs
• Modern technology for remote collaboration

Responsibilities

• Establish and implement process and technology standards for all eCOA projects to ensure quality and timeliness
• Manage offshore testing vendors, including resource management and capacity planning
• Redefine validation processes leveraging best practices and AI/automation
• Set software quality standards for study configuration lifecycle, documentation, development, testing and maintenance
• Oversee day-to-day QA department operations, including people management and conflict resolution
• Improve department efficiency while maintaining quality through best practices and automation
• Partner with HR on hiring, development, and performance management
• Allocate SQE resources across squads as needed
• Develop and report KPIs to ensure quality, timeliness, and productivity
• Supervise SQE Managers, hire/train staff, and address technical challenges
• Maintain Service Delivery QA SOPs and attend project reviews
• Provide guidance on testing approaches, schedules, estimations, and regulatory expectations
• Monitor testing progress, mitigate risks, and communicate plans to keep projects on track
• Manage QA tools (JIRA, GIT, Jama) and respond to audit observations with CAPAs
• Review project statuses and address risks to meet target dates
• Implement new tools and processes as needed
• Support individual development plans for team members
• Oversee offshore Quality Assurance/Validation partnerships

Key requirements

• BS, BA or equivalent in Information Technology or related field
• Minimum 12 years’ Global Clinical Operations experience or 12+ years in Software Delivery Operations
• Minimum 10 years of software validation experience in a regulated environment
• Proven experience in Test Automation and AI is a strong plus

• leadership
• stakeholder management
• communication
• Test Automation
• AI in testing
• JIRA

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