RC-REGULATORY COMPLIANCE-Veeva BA-Senior

We are seeking a Senior Business Analyst with strong consulting skills and deep expertise in Veeva Vault applications to support IT implementations in regulated GxP environments. This role focuses on requirements gathering, workflow design, validation documentation, and data migration planning for Veeva-based solutions across the pharmaceutical lifecycle.

Role Overview

As a Business Analyst, you will work closely with clients and cross-functional teams to translate business needs into functional specifications, lead workshops, and ensure compliance with global regulatory standards. You will contribute to projects involving Veeva Vault Clinical, RIM, Quality and Safety suite, enabling successful deployments and integrations within highly regulated environments.

Your key responsibilities

• Gather, analyze, and document business requirements for Veeva Vault implementations (Clinical, RIM, Quality, Safety suite).
• Lead workshops for requirements gathering, as-is/to-be process analysis, workflow design, and data mapping between legacy and Veeva systems.
• Develop data migration strategies, including field mapping, transformation rules, and validation of migrated data.
• Collaborate with technical teams to ensure accurate translation of requirements into Veeva configurations.
• Support creation of validation documentation (e.g., URS, FRS, IQ/OQ/PQ) and ensure compliance with GxP and CSV/CSA guidelines.
• Facilitate requirement traceability and manage UAT planning and execution using tools like qTest, ALM, and JIRA.
• Build dashboards and reports to track progress, risks, and testing outcomes.
• Act as a liaison between business and technology teams, driving clarity and alignment on deliverables.
• Support business development initiatives, including assisting senior leadership with client pursuits and RFP responses.

Qualifications

• Bachelor s degree in computer science, Information Technology, Life Sciences or a related field.
• 4-7 years of experience as a Business Analyst in IT projects within regulated environments.
• Hands-on experience with Veeva Vault applications (Clinical, RIM, Quality, Safety) with demonstrated expertise in related business processes and workflows
• Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
• Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
• Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.

Must-Have Skills & Attributes

• Proven experience in requirements gathering and documentation using tools like JIRA, Confluence, ALM, Lucid, Visio, Mural, etc.
• Familiarity with Veeva Vault configuration concepts (objects, lifecycles, workflows, security roles).
• Strong understanding of GAMP 5 methodology, System Development Life Cycle (SDLC), and validation planning
• Proficiency in testing and validation tools such as qTest and ALM, with strong dashboarding and reporting capabilities.
• Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs, Safety, Regulatory)
• Experience in client-facing roles, managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Familiarity with change control, deviation handling, and CAPA processes
• Proven ability to mentor junior resources
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset
• Veeva Vault admin certification

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Exposure to regulatory compliance (FDA, EMA) and audit remediation.
• Ability to create innovative insights and contribute to thought leadership
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities