Responsibilities:
- Lead and manage the UAT Services team responsible for the planning, development, execution, and documentation of UAT across multiple systems.
- Collaborate with business stakeholders, system owners, project managers, and QTC to define UAT strategy, scope, and success criteria.
- Develop and maintain standard operating procedures (SOPs), templates, and best practices related to UAT planning and execution in a regulated environment.
- Oversee the creation and review of UAT deliverables including test plans, test scripts, traceability matrices, test data, and summary reports.
- Manage the UAT test execution lifecycle, including defect tracking, resolution coordination, retesting, and final sign-off.
- Ensure UAT activities are aligned with applicable regulatory and compliance standards such as 21 CFR Part 11, GAMP 5, GxP, and ICH-GCP.
- Monitor and report UAT progress, risks, and quality metrics to project teams and senior leadership.
- Provide leadership, mentorship, and performance management for UAT staff, including testers and business analysts.
- Serve as the point of escalation for UAT-related issues and decision-making.
- Continuously assess and improve UAT processes, toolsets, and team capabilities.
- Support audits and inspections by ensuring audit-ready documentation and compliance with internal and external quality requirements.
Education:
- Bachelor’s degree in Life Sciences, Computer Science, Information Technology, or a related field.
Experience:
- 6+ years of experience in software/system testing in regulated industries, with at least 2–3 years in a leadership or management role.
- Proven expertise in UAT planning and execution for enterprise clinical systems, including RTSM, EDC, and CTMS.
- Deep understanding of regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), SDLC, and computer system validation (CSV) principles.
- Strong leadership, communication, and stakeholder management skills.
- Proficient in test management and defect tracking tools such as JIRA, SpiraTeam, Azure DevOps or similar.
- Ability to manage multiple priorities and lead cross-functional teams in a fast-paced, dynamic environment
Skills:
- Strong collaboration and development skills.
- Proactive team player enthusiastic with high work ethics
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What We Do
Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.
Why Work With Us
We’re located all around the globe, creating a fun, collaborative culture, driven by a passion for what we do. Through the power of technology, we’re able to work productively, communicate frequently and engage in fun activities throughout the year no matter where we are.
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