Veeva QMS Configuration Manager

Role Overview EY is seeking an experienced Veeva QMS Configuration Manager to lead Digital Quality Management System implementations within regulated GxP environments. This is a senior leadership role requiring deep expertise in Veeva Vault platform configuration, regulatory compliance, and cross-functional stakeholder engagement. The ideal candidate will combine strategic thinking with hands-on technical capability to deliver compliant, scalable digital QMS solutions for global life sciences and pharmaceutical clients. Key Responsibilities - Lead end-to-end Digital QMS implementations covering Deviations, CAPA, Change Control, Audit Management, Quality Risk Management, Supplier Quality, and Complaints modules in Veeva Vault - Design and configure workflows, object lifecycles, security roles, page layouts, and reporting tools aligned with client quality processes and regulatory standards - Collaborate with Business, Quality, IT, and Validation teams to translate functional requirements into compliant Vault configurations - Support data migration activities using Vault Loader and Veeva APIs, ensuring data integrity and full traceability - Design and manage system integrations between Veeva Vault and enterprise platforms such as SAP, LIMS, MES, and DMS - Author and maintain system documentation including configuration specifications, design documents, and validation protocols such as IQ, OQ, and PQ - Ensure compliance with GxP, CSV/CSA, and 21 CFR Part 11 regulatory requirements across all implementation activities - Participate in release management including change impact assessments, regression testing, and deployment planning across sandbox and production environments - Mentor junior developers, support knowledge transfer, and contribute to team capability building - Support client audits, inspections, and regulatory assessments related to QMS systems - Lead, coach, and manage a team of Digital QMS consultants, validation analysts, and technical staff - Conduct performance reviews, manage work allocation, and support hiring and onboarding initiatives Required Qualifications - Bachelor's degree in Computer Science, Information Technology, or a related technical discipline - 8 to 12 years of hands-on experience in Veeva Vault development with a strong focus on QMS modules - Proven proficiency in configuring Veeva Vault objects, fields, roles, workflows, lifecycles, and reporting tools - Strong knowledge of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements - Experience with Vault Loader, Veeva APIs, and integration tools for data migration and system interoperability - Demonstrated experience managing teams, vendors, and complex stakeholders in client-facing roles - Proficiency in GAMP 5 methodology and Software Development Life Cycle practices - Experience working in Agile or Scrum environments - Veeva Associate Administrator certification preferred Why Join Us At EY, you will be part of a market-leading multidisciplinary team of over 1,400 professionals working on meaningful, high-impact projects across global industries. EY offers structured career development, coaching from senior colleagues, and the flexibility to grow at your own pace within a culture that values quality, innovation, and continuous learning.

- 8 to 12 years of hands-on experience in Veeva Vault development focused on QMS modules - Strong proficiency in Vault configuration including objects, workflows, lifecycles, security roles, and reporting - Experience with Vault Loader and Veeva APIs for data migration and system integration - Deep knowledge of GxP regulations, CSV/CSA frameworks, and 21 CFR Part 11 compliance - Familiarity with GAMP 5 methodology and SDLC practices - Experience managing cross-functional teams and client-facing delivery - Strong understanding of QMS processes including Deviation, CAPA, Change Control, Audit, and Complaints - Experience with enterprise system integrations such as SAP, LIMS, MES, and DMS - Excellent communication, documentation, and presentation skills - Proven ability to mentor junior resources and lead knowledge-sharing initiatives - Veeva Associate Administrator certification is preferred - Experience in IT project management and validation planning - Exposure to AI or automation usage in regulated systems is a plus

- Competitive compensation in the range of 27.5 to 32.5 LPA - Hybrid work model with flexibility across Noida, Hyderabad, and Bengaluru - Structured career development and individual progression planning - Coaching and mentoring from senior global professionals - Exposure to Fortune 500 clients across global markets - Access to EY's global consulting practices and cross-industry projects - Continuous learning culture with focus on upskilling and certifications - Collaborative and interdisciplinary work environment