Title: Sr RBV and VM Technical Business System Analyst

Location: CA/Remote

Type: Contract

JD:

Sr RBV and VM Technical Business System Analyst

Key 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.

Must Have Skills:

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.

Nice to Have Skills:

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.

Optimuss Inc.

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