Business Analyst- Risk-based quality management (RBQM)

Job Title: **Business Analyst** **Risk\-based quality management (RBQM)** Location: **Onsite, San Jose CA No remote** Job Type: **FTE** **Job Description:** **Minimum 10 yrs** **Primary skills:** 8\+ years of experience in Business Analysis, Clinical Systems Support, or **Clinical Operations Technology**. Must understand **GXP system validation** process Must be familiar with **AWS environments**. Working understanding of risk\-based quality management **(RBQM)** Experience working with statisticians and **Clinical Operations risk managers** Basic **SQL skills** for data analysis and data verification. Basic **Python** skills for data analysis. Knowledge of **clinical operations processes and GxP/regulatory environments is preferred.** Educational Qualification: \***Any Bachelor's Degree** Experience Range: **10\+ Years** Tagline/Tech Stack Snapshot \- BA Experience Role Summary \- (To be filled by Practice /DO): We are seeking a Business Analyst with requirement gathering, documentation, and stakeholder engagement within the clinical domain. Individual contributor partnering with Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the RBQM data pipeline Leads requirements refinement, including current/future state analysis, requirements documentation, prioritization, and stakeholder alignment. Refine existing user and functional requirements specification. Owns User Acceptance Testing planning and execution. Partners with the Validation team to ensure testability of requirements and release readiness. Primary (Must have skills)\* \- To be Screened by TA Team 8\+ years of experience in **Business Analysis, Clinical Systems Support, or Clinical Operations Technology**. Must understand **GXP system validation process** **Must be familiar with AWS environments.** Working understanding o