RC - REGULATORY COMPLIANCE - QMS - BA - Veeva - Manager

EY; Chennai District; Sur place; INR 2 400 000 - 4 000 000; Plein temps

Résumé du poste

EY's Regulatory Compliance team seeks a Manager – Business Analyst with deep Veeva Vault experience to lead IT implementation projects in regulated environments. You will own client relationships, guide requirements, design processes, and oversee validation planning for Quality, Safety, RIM, and Clinical suites.

You will mentor juniors, support business development, and drive governance across SDLC, Agile, and CSV/CSA frameworks in a fast-paced consulting setting.

Qualifications

• Bachelor’s degree in computer science, information technology, life sciences or related field.
• 8–12 years of experience as a Business Analyst in IT projects within regulated environments, with 3–5 years in a leadership capacity.
• Strong understanding of QMS/Safety/Regulatory/Clinical processes and how these are structured into workflows within Veeva Vault applications (Quality/Safety/RIM/Clinical).
• Proven experience managing large-scale Veeva Vault implementation projects.
• Strong understanding of SDLC, Agile methodologies, and GxP compliance frameworks.
• Expertise in CSV/CSA methodologies, validation planning, and audit readiness.
• Exceptional communication, stakeholder management, and client engagement skills.

Responsabilités

• Lead end-to-end delivery of Business Analysis workstreams for Veeva Vault Quality, Safety, RIM, and Clinical Suites.
• Drive requirements management, including workshops for as‑is/to‑be analysis, workflow design, and data mapping between legacy and Veeva systems.
• Oversee data migration and system integration planning, ensuring alignment with business processes and compliance requirements.
• Provide strategic guidance on validation planning, including authoring and reviewing documentation (Validation Plan, URS, FRS, IQ/OQ/PQ, Validation Report).
• Manage requirement traceability and testing governance using JIRA, Confluence, qTest, and ALM.
• Develop dashboards and reporting frameworks for project performance, risks, and compliance tracking.
• Act as a trusted advisor to clients, ensuring stakeholder alignment and managing expectations at senior leadership levels.
• Mentor and coach junior team members, fostering a culture of collaboration and continuous improvement.
• Support business development initiatives, including assisting senior leadership with client pursuits, drafting RFP responses, and delivering impactful presentations.
• Contribute to thought leadership and internal capability-building initiatives within Regulatory Compliance practice.

Connaissances

Veeva Vault

Regulatory Compliance

Stakeholder Mgmt

Project Governance

Data Migration

Validation Planning

JIRA/Confluence

Leadership

Business Analysis

Formation

Bachelor's degree

Outils

JIRA

Confluence

qTest

ALM

Description du poste

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all.

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager - Business Analyst (Veeva Vault Suite – Life Sciences)

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Manager actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We are seeking an experienced Manager – Business Analyst with strong consulting skills and deep expertise in Veeva Vault applications to lead IT implementation projects in regulated GxP environments. This role combines delivery leadership, stakeholder engagement, and business development support to drive successful outcomes across Veeva-based solutions for the pharmaceutical lifecycle.

Role Overview

As a Manager, you will own client relationships, lead teams of analysts, and ensure high-quality delivery of Veeva Vault projects. You will guide requirements definition, process optimization, validation planning, and data migration/integration strategies, while also supporting senior leadership in client pursuits and RFP responses. This role demands strong consulting acumen, ability to manage complex programs, and a focus on operational excellence.

Your Key Responsibilities

• Lead end-to-end delivery of Business Analysis workstreams for Veeva Vault Quality Suite, Safety Suite, RIM Suite, Clinical Suite
• Drive requirements management, including workshops for as-is/to-be analysis, workflow design, and data mapping between legacy and Veeva systems.
• Oversee data migration and system integration planning, ensuring alignment with business processes and compliance requirements.
• Provide strategic guidance on validation planning, including authoring and reviewing documentation (Validation Plan, URS, FRS, IQ/OQ/PQ, Validation Report).
• Manage requirement traceability and testing governance using tools like JIRA, Confluence, qTest, and ALM.
• Develop dashboards and reporting frameworks for project performance, risks, and compliance tracking.
• Act as a trusted advisor to clients, ensuring stakeholder alignment and managing expectations at senior leadership levels.
• Mentor and coach junior team members, fostering a culture of collaboration and continuous improvement.
• Support business development initiatives, including assisting senior leadership with client pursuits, drafting RFP responses, and delivering impactful presentations.
• Contribute to thought leadership and internal capability-building initiatives within the Regulatory Compliance practice.

Qualifications:

• Bachelor’s degree in computer science, Information Technology, Life Sciences or a related field, advanced degree preferred.
• 8-12 years of experience as a Business Analyst in IT projects within regulated environments, with at least 3–5 years in a leadership capacity.
• Strong understanding of QMS/ Safety/ Regulatory/ Clinical processes and how these are structured into workflows within Veeva Vault applications (Quality Suite/ Safety Suite/ RIM Suite/ Clinical)
• Proven experience managing large-scale Veeva Vault implementation projects.
• Strong understanding of SDLC, Agile methodologies, and GxP compliance frameworks.
• Expertise in CSV/CSA methodologies, validation planning, and audit readiness.
• Exceptional communication, stakeholder management, and client engagement skills.

Must-Have Skills & Attributes

• Deep knowledge of Veeva Vault configuration concepts (objects, lifecycles, workflows, security roles).
• Ability to lead complex workshops for requirements, process design, and data migration mapping.
• Strong proficiency in requirements and testing tools (JIRA, Confluence, qTest, ALM) and dashboard/reporting solutions.
• Experience in system integration planning and business process alignment.
• Demonstrated success in client-facing roles, managing senior stakeholders and delivering strategic solutions.
• Strong leadership skills with experience in mentoring and team development.
• Ability to troubleshoot issues, manage risks, and drive resolution in high-pressure environments.
• Familiarity with change control, deviation handling, and CAPA processes.
• Experience in IT project management and governance.
• Veeva Vault admin certification

Good-to-Have Skills & Attributes

• Exposure to business development activities, including client pursuits and RFP support.
• Familiarity with regulatory compliance frameworks (FDA, EMA) and audit remediation.
• Experience in process optimization and operational efficiency initiatives.
• PMP Certification preferred
• Ability to align technology with business transformation goals
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

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

EY | Building a better working world

EY exists to build a better working world, helping to create long‑term value for clients, people and society and build trust in the capital markets.

Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate.

Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.