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Manager, Regulatory Compliance – Digital QMS
EYManager at EY supporting global life sciences clients in designing and implementing Veeva Vault QMS. Lead complex projects ensuring compliance with regulatory standards in highly regulated environments.
Tech Stack
Tools & technologiesSDLCVault
About the role
Key responsibilities & impact- Lead and oversee Digital QMS (Veeva) Initiatives including Deviations, CAPA, Change Control, Audit Management, Quality Risk Management (QRM), Supplier Quality and Complaints, ensuring alignment with client-specific quality processes and regulatory requirements.
- Design and implement workflows, object lifecycles, security roles, and page layouts and reports aligned with client quality processes to support scalable and compliant quality operations.
- Collaborate with Business, Quality, IT, and Validation teams to translate functional requirements into compliant Vault configurations
- Support data migration activities using Vault Loader and APIs, ensuring data integrity and traceability
- Design and support system integrations between Veeva Vault and enterprise systems (SAP, LIMS, MES, DMS, etc.)
- Author and maintain comprehensive system documentation, including configuration specifications, design documents, validation protocols (IQ/OQ/PQ), and user guides.
- Provide expert-level troubleshooting and impact analysis, resolving system issues efficiently while minimizing disruption to business operations.
- Ensure system compliance with global regulatory standards including GxP, CSV/CSA, and 21 CFR Part 11, incorporating best practices in validation and audit readiness.
- Participate in release management activities, including change impact assessments, regression testing, and deployment planning across sandbox and production environments.
- Act as a trusted advisor to clients, offering strategic guidance on Vault QMS capabilities, roadmap planning, and optimization opportunities.
- Mentor junior developers and support knowledge sharing and capability building within the team.
- Support audits, inspections, and regulatory assessments related to QMS systems.
- Identify opportunities for process harmonization, standardization, and digital enablement across laboratories.
- Lead, coach, and mentor Digital QMS consultants, validation analysts, and technical team members
- Manage work allocation across Digital QMS engagements, ensuring quality delivery and adherence to timelines
- Conduct performance reviews, feedback, and development planning
- Support hiring, onboarding, training, and knowledge transfer initiatives
- Foster a culture of quality, accountability, and continuous improvement.
Requirements
What you’ll need- Bachelor’s degree in computer science, Information Technology, or a related technical discipline.
- Proven proficiency in configuring the Veeva Vault platform, including objects, fields, roles, workflows, lifecycles, and reporting tools.
- Familiarity with Veeva APIs, Vault Loader, and other integration tools for data migration and system interoperability.
- 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.
- 8-12 years of hands-on experience in Veeva Vault development (objects, workflows, lifecycles, security, reporting), with a strong focus on Quality Management System (QMS) modules.
- Strong understanding of QMS processes (Deviation, CAPA, Change Control, Audit, Complaints)
- Proficiency with Vault Loader, Veeva APIs, and release management practices
- Demonstrated experience managing teams, vendors, or complex stakeholders
- Ability to operate at a managerial level, balancing delivery and people leadership
- GAMP 5 methodology and system development life cycle (SDLC)
- Ability to collaborate with cross-functional teams (QA, IT, Digital, Commercial, Manufacturing, Labs)
- Experience in client-facing roles, managing expectations and delivering solutions
- Strong communication and presentation skills
- Experience in IT project management and validation planning
- Ability to troubleshoot application issues and recommend solutions
- Proven ability to mentor junior resources
- Experience in training and cross-skilling resources
- Strong teamwork and collaboration mindset
- Veeva associate administrator level certification
Benefits
Comp & perks- Support, coaching and feedback from some of the most engaging colleagues around
- Opportunities to develop new skills and progress your career
- The freedom and flexibility to handle your role in a way that’s right for you
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Veeva Vault configurationdata migrationAPI integrationAgile methodologyGxP complianceCSV/CSA methodologiesQuality Management System (QMS)release managementtroubleshootingsystem development life cycle (SDLC)
Soft Skills
analytical skillsproblem-solvingcommunicationclient interactionteam managementmentoringcollaborationleadershipcontinuous improvementtraining
Certifications
Veeva associate administrator level certification