Business Analyst- Risk-based quality management (RBQM)

Falcon Smart IT (FalconSmartIT); San Jose (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Falcon Smart IT (FalconSmartIT) is looking for a Business Analyst specializing in risk-based quality management (RBQM) in San Jose, CA. The position requires extensive experience in business analysis, particularly within clinical systems and operations, with a focus on requirement gathering and stakeholder engagement.

The ideal candidate should have a strong understanding of GXP validation and AWS environments, as well as skills in SQL for data analysis. Key responsibilities include leading requirements refinement and user acceptance testing while ensuring the timely delivery of high-quality solutions.

Qualifications

• 8+ years of experience in Business Analysis, Clinical Systems Support, or Clinical Operations Technology.
• Must understand GXP system validation process.
• Experience Required: 10+ years in relevant fields.

Responsibilities

• Partner with Business Process Owners and Project Managers for requirements documentation.
• Lead requirements refinement and stakeholder alignment.
• Own User Acceptance Testing planning and execution.

Skills

Business Analysis

GXP system validation

AWS environments

Risk-based quality management (RBQM)

Basic SQL skills

Clinical operations processes

Education

Bachelor's Degree

Tools

Jira

Azure DevOps

Job description

Job Title: Business Analyst Risk-based quality management (RBQM)

Location: Onsite, San Jose CA – No remote

Job Type: Full Time Employee (FTE)

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
• Knowledge of clinical operations processes and GxP/regulatory environments is preferred

Educational Qualification: Any Bachelor's Degree

Experience Required: 10+ years

Role Summary

We are seeking a Business Analyst with a focus on requirement gathering, documentation, and stakeholder engagement within the clinical domain. The candidate will partner with Business Process Owners, Project Managers, and the Validation team to deliver complex business and system requirements for the RBQM data pipeline.

What You'll Do

• Partner with Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the RBQM data pipeline
• Lead requirements refinement, including current/future state analysis, requirements documentation, prioritization, and stakeholder alignment
• Refine existing user and functional requirements specification
• Own User Acceptance Testing planning and execution
• Partner with the Validation team to ensure testability of requirements and release readiness
• Experience with Agile/Scrum projects and tools such as Jira or Azure DevOps

Expected Outcome

The Business Analyst will ensure that business requirements are clearly understood, documented, and translated into actionable deliverables, driving the successful implementation of clinical systems and processes. The role is expected to deliver solutions that meet business objectives, comply with industry standards, and are delivered on time with high quality.