RC-REGULATORY COMPLIANCE-Digital QMS - CA Veeva-Manager

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 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.

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 continuous improvement

Decision-Making Responsibilities:

• Make informed decisions on delivery approach, validation strategy, and risk mitigation for digital lab programs
• Assess system, data, and compliance risks and proactively escalate issues to clients and EY leadership
• Support leadership in workforce planning, solution design, and practice development for Digital Lab offerings
• Guide decisions on vendor coordination, system design tradeoffs, and implementation timelines
• Apply structured and analytical thinking to improve delivery efficiency and client outcomes.

Qualifications:

• 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.

Must-Have Skills & Attributes

• 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

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Good knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11)
• Ability to create innovative insights and contribute to thought leadership
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities
• Contribution to process optimization, accelerators, or reusable assets
• Exposure to AI/automation usage in regulated systems and governance considerations

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• 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