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Job Description & How to Apply Below
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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager (Veeva Vault QMS)
The opportunity
EY is seeking an experienced Manager with deep expertise to support global life sciences clients in designing, configuring, and implementing Veeva Vault Quality Management Systems (QMS) in highly regulated environments. This role is ideal for professionals with deep Veeva Vault technical expertise, strong understanding of GxP compliance, and experience delivering validated, scalable QMS solutions.
You will work closely with Quality, IT, Validation, and Business stakeholders to translate quality and compliance requirements into robust Vault configurations that align with global regulatory standards and client quality strategies.
Role Overview
As a Manager at Regulatory Compliance, you will lead Digital QMS (Veeva) implementations in regulated GxP environments, leveraging your deep expertise in Digital QMS (Veeva). You will also provide technical leadership within projects and mentor junior resources.
Your primary responsibility will be to partner with clients to understand their business needs and translate strategic objectives into integrated, compliant, and practical digital QMS solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with EY's commitment to data integrity, quality, and regulatory compliance.
This is a leadership role that demands strategic thinking, strong stakeholder engagement, and a passion for delivering excellence across complex laboratory operations in a highly regulated environment.
Your
Key Responsibilities
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 life cycles, 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.
People Responsibilities:
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…
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