RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior

EY

5–7 yrs Hyderabad Full Time Hybrid (office + remote)
EY logo
Posted : today
Actively hiring

Job description

Join EY's Enterprise Risk – Regulatory Compliance team as a Senior Veeva Vault QMS Developer. This role focuses on designing, configuring, and implementing Veeva Vault Quality Management Systems for global life sciences clients in regulated environments. Ideal for professionals with strong Veeva technical expertise, GxP compliance knowledge, and experience delivering validated QMS solutions.

Collaborate with Quality, IT, Validation, and Business stakeholders to translate compliance needs into robust Vault configurations that meet global regulatory standards and client quality strategies.

Responsibilities

Configure, customize, and deploy Veeva Vault QMS modules including Deviations, CAPA, Change Control, and Audit Management. Design and implement workflows, lifecycles, security roles, and reports aligned with client quality processes. Support data migration using Vault Loader and APIs, and design integrations with enterprise systems. Author system documentation and validation protocols. Provide expert troubleshooting and ensure system compliance with GxP, CSV/CSA, and 21 CFR Part 11.

Participate in release management, conduct change impact assessments, and act as a trusted advisor to clients on Vault QMS capabilities and optimization. Mentor junior developers and foster knowledge sharing within the team.

Qualifications

A Bachelor’s degree in Computer Science, Information Technology, or a related technical field is required. Proven expertise in Veeva Vault configuration, including objects, workflows, lifecycles, and security, is essential. Familiarity with Veeva APIs, Vault Loader, and integration tools is necessary.

Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements is critical. Experience in Agile/Scrum environments and strong analytical, problem-solving, communication, and documentation skills are expected.

Essential Skills

Veeva Vault QMSVeeva APIsVault LoaderGxP ComplianceCSV/CSA21 CFR Part 11Quality Management Systems (QMS)DeviationsCAPAChange ControlAudit ManagementQuality Risk Management (QRM)Supplier QualityComplaintsAgile/ScrumSDLCGAMP 5System IntegrationsValidation LifecycleTechnical Leadership

Good to Have

Business DevelopmentClient EngagementProcess OptimizationAI/Automation

Highlights

  • Actively hiring

More Details

RoleRC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior
IndustryManagement Consulting, Information Technology & Services, Biotechnology, Pharmaceuticals
DepartmentQuality Assurance, Software Development
Employment TypeFull Time, Hybrid (office + remote)

About the Company

EY Global Delivery Services ( EY GDS) logo

EY Global Delivery Services ( EY GDS)

Management Consulting

RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior at EY | SkillMX | SkillMX