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Regulatory Compliance Manager – QMS, Veeva
EYEY Manager leading Veeva Vault Business Analysis and compliance implementations for pharmaceutical clients. Guiding requirements, validation, migration, integration and senior stakeholder delivery.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Business Analysis within regulated environments, particularly with Veeva Vault applications, while effectively managing stakeholder relationships and leading project teams. Proficient in validation planning, system integration, and compliance frameworks, ensuring high-quality deliverables and strategic solutions.
Highest-signal resume keywords
Veeva Vault ImplementationBusiness AnalysisSDLC and Agile MethodologiesJIRA and Confluence ProficiencyLeadership and Mentoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Business AnalysisValidation PlanningData MigrationProcess DesignRequirements TraceabilityQMS and Regulatory ProcessesCSV/CSA MethodologiesSystem Integration PlanningDashboard DevelopmentOperational Efficiency
Soft Skills
Stakeholder ManagementClient EngagementCommunicationProblem-SolvingDecision-Making
Tools & Technologies
JIRAConfluenceQTestALMVeeva Vault
Certifications & Qualifications
Veeva Vault Admin Certification
Industry Keywords
GxP ComplianceFDA Regulatory ComplianceEMA Regulatory ComplianceChange ControlCAPA Processes
Tech Stack
Tools & technologiesSDLCVault
About the role
Key responsibilities & impact- Help clients understand business needs and deliver solutions using EY guidelines and methodologies
- Establish, maintain and strengthen internal and external relationships
- Drive projects to completion with high-quality deliverables
- Identify and raise risks with clients and EY senior management
- Lead end-to-end Business Analysis workstreams for Veeva Vault Quality, Safety, RIM and Clinical Suites
- Conduct as-is/to-be analysis, workflow design and data mapping workshops
- Oversee data migration and system integration planning
- Provide strategic guidance on validation planning and author/review validation documentation
- Manage requirement traceability and testing governance using JIRA, Confluence, qTest and ALM
- Develop dashboards and reporting frameworks for project performance, risks and compliance tracking
- Act as a trusted client advisor and manage senior stakeholder expectations
- Mentor and coach junior team members
- Support client pursuits, RFP responses and presentations
- Contribute to thought leadership and internal capability-building initiatives
Requirements
What you’ll need- Bachelor’s degree in computer science, Information Technology, Life Sciences or a related field
- 8–12 years of experience as a Business Analyst in IT projects within regulated environments
- At least 3–5 years in a leadership capacity
- Strong understanding of QMS, Safety, Regulatory and Clinical processes within Veeva Vault applications
- Proven experience managing large-scale Veeva Vault implementation projects
- Strong understanding of SDLC, Agile methodologies and GxP compliance frameworks
- Expertise in CSV/CSA methodologies, validation planning and audit readiness
- Exceptional communication, stakeholder management and client engagement skills
- Deep knowledge of Veeva Vault configuration concepts, including objects, lifecycles, workflows and security roles
- Ability to lead complex workshops for requirements, process design and data migration mapping
- Strong proficiency in JIRA, Confluence, qTest, ALM and dashboard/reporting solutions
- Experience in system integration planning and business process alignment
- Demonstrated success in client-facing roles managing senior stakeholders and delivering strategic solutions
- Strong leadership skills with experience in mentoring and team development
- Ability to troubleshoot issues, manage risks and drive resolution in high-pressure environments
- Familiarity with change control, deviation handling and CAPA processes
- Experience in IT project management and governance
- Veeva Vault admin certification
- Exposure to business development, client pursuits and RFP support
- Familiarity with FDA and EMA regulatory compliance frameworks and audit remediation
- Experience in process optimization and operational efficiency initiatives
- Ability to align technology with business transformation goals
- Adaptability to changing regulatory and business environments
- Strong problem-solving and decision-making abilities
Benefits
Comp & perks- Support, coaching and feedback from engaging colleagues
- Opportunities to develop new skills and progress your career
- Education and coaching alongside practical experience
- Individual progression plan
- Freedom and flexibility to handle the role in a way that’s right for you
- Inspiring and meaningful projects
- Interdisciplinary environment emphasizing high quality and knowledge exchange