CHENNAI · FULLTIME
RC - REGULATORY COMPLIANCE - QMS - BA - Veeva - Manager
Ernst Young
Chennai · onsite · Posted 4d ago
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Undisclosed7–12 yrsfulltimeChennai
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Section · 01
About this role
EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager - Business Analyst (Veeva Vault Suite Life Sciences)
At EY, youll 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 were 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.
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, youll 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.
- Bachelors 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 35 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.
- 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
- 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
- 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
At EY, were dedicated to helping our clients, from startups 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
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Section · 02
Skills
AlmAgilebusiness processConfluenceBusiness Analystdata mappingCSVCAPAChange ControlBusiness AnalysisDashboardAuthoringCapital MarketsBusiness DevelopmentBusiness Transformationcompliance
Section · Company
About Ernst & Young
Ernst Young
Management Consulting
44k+
employees
2002
24 years old
Gurgaon / Gurugram, Haryana
India
₹15.3L PA avg
Avg at Ernst & Young
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