• Provide end-to-end quality oversight for commercial and digital health assets, mobile applications including health software and SaMD applications, and websites used in support of clinical and commercial operations.• Review and approve validation deliverables of GxP computerized systems to ensure full compliance with Health Authority regulatory requirements and align to company policies.• Ensure outstanding Inspection Readiness for Systems in the portfolio, with the purpose of minimizing the risk of inspection observations to business systems/infrastructure

Responsibilities as a Product Owner include:• Work closely with Product Manager to align on the vision, program backlog, and roadmap• Translate high-level strategy and product direction into features, epics and user stories• Prioritize the backlog according to business goals and strategic objectives while focusing on building and delivering the most business valueResponsibilities as a Business Analyst include:• Elicit stakeholder requirements via requirement workshops, interviews, document analysis, and process modeling.• Liaise between business and technical teams to ensure a mutual understanding of business processes and applications• Create business context diagrams to help identify all stakeholders, outline scope, and define project vocabulary to ensure team alignment.• Perform GAP analysis of business rules, requirements, and system process flows to identify any missing requirements.• Define Use Case Scenarios and User Stories based on the requirements; map these items within a baseline framework to ensure traceability.Responsibilities as an SQA Lead Include:• Manage and lead multiple SQA teams onshore and offshore across multiple projects• Design test strategies for integrated system and regression testing on both web and mobile applications• Developed and implemented the verification testing process for GxP applications within the Digital Health space• Maintain a test case repository in HP-ALM of over 500 test scripts which trace back to user stories, functional and technical specifications• Work with the development team to perform root cause analysis on over 100 defects to decrease defect density• Ensure system and user acceptance testing is executed and approved in HP-ALM/XRAY prior to release