STAFFWORXSRemote
Sr RBV and VM Technical Business System Analyst
United States of America
Full Time
4 hours ago
No H1B
Key skills
CSA implementationGAMP 5 implementationVeeva validation managementVeeva configurationsSystem validationRequirements documentationTest script developmentTraceability documentationRisk assessmentGap analysisRegulatory complianceAIOpenAIAnalyticsProduct ManagementCommunication
About this role
Staffworxs is a company that powers transformation through its Digital & Data Analytics practice. They are seeking a Senior RBV and VM Technical Business System Analyst to lead system analysis and validation efforts, manage Veeva validation documentation, and collaborate with teams for successful implementation.
Responsibilities:
- Lead and execute system analysis and validation efforts following CSA and GAMP 5 methodologies
- Handson experience performing Veeva configurations, creating reports and dashboard
- Develop and manage Veeva validation documentation including requirements, test scripts, traceability, and risk assessments
- Collaborate with global and virtual teams to define system requirements and ensure successful implementation
- Perform gap analyses, identify risks, and recommend mitigation strategies to ensure compliance and operational efficiency
- Work closely with IT, Quality, and Business stakeholders to ensure alignment between technical solutions and business needs
- Serve as a subject matter expert in system validation, providing guidance and mentorship to project teams
- Manage multiple initiatives concurrently, ensuring on-time delivery and adherence to regulatory standards
- Support ongoing process improvements to enhance system reliability and compliance posture
Requirements:
- Proven experience in CSA and GAMP 5 implementation
- Strong knowledge of Veeva validation management and Veeva configurations
- Excellent analytical and problem-solving skills
- Strong verbal and written communication abilities
- Demonstrated ability to work effectively with global, virtual teams
- Experience working independently, guiding project teams, and making informed decisions
- Prior hands-on experience with CSA and GAMP 5 implementation projects
- Experience implementing OpenAI or AI-driven use cases in business systems
- Proven ability to manage multiple priorities and deliver results under tight timelines
- Strong presentation and public speaking skills
- Experience collaborating with Product Owners, Service Owners, and delivery teams to ensure service quality and resolve escalations
- Experience working with cross-functional teams—including product management, design, and QA—to deliver compliant, high-quality solutions