Join EY's Global Delivery Services (GDS) Consulting team as a Manager in Enterprise Risk, focusing on Regulatory Compliance and Business Analysis within the Life Sciences sector. This role involves leveraging your expertise in Veeva Vault applications to lead IT implementation projects in regulated GxP environments.

As a key member of our Regulatory Compliance team, you will be instrumental in understanding client business needs and delivering solutions aligned with EY's methodologies. You will cultivate and strengthen both internal and external relationships, ensuring high-quality project deliverables and operational efficiency. Proactively identifying and escalating risks to clients and EY senior management will be a core aspect of your responsibilities, alongside leading internal team initiatives.

This opportunity offers a chance to build a unique career, supported by EY's global scale, inclusive culture, and advanced technology. Your contributions will be vital in enhancing EY's capabilities and fostering a better working world.

Lead comprehensive Business Analysis workstreams for Veeva Vault Quality, Safety, RIM, and Clinical Suites.

Drive requirement gathering through workshops for current and future state 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 mandates.

Provide strategic guidance on validation planning, including the creation and review of critical documentation like Validation Plans, URS, FRS, IQ/OQ/PQ, and Validation Reports.

Manage requirement traceability and testing governance using tools such as JIRA, Confluence, qTest, and ALM.

Develop performance metrics, risk, and compliance tracking dashboards and reporting frameworks.

Serve as a trusted advisor, ensuring stakeholder alignment and managing expectations at senior leadership levels.

Mentor and develop junior team members, promoting collaboration and continuous improvement.

Support business development efforts, including client pursuits, RFP responses, and impactful presentations.

Contribute to thought leadership and internal capability development within the Regulatory Compliance practice.

A Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related field is required; an advanced degree is preferred.

Possess 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.

Demonstrate a strong grasp of QMS, Safety, Regulatory, and Clinical processes and their implementation within Veeva Vault applications (Quality, Safety, RIM, Clinical Suites).

Exhibit proven experience managing large-scale Veeva Vault implementation projects.

Show a solid understanding of SDLC, Agile methodologies, and GxP compliance frameworks.

Expertise in CSV/CSA methodologies, validation planning, and audit readiness is essential.

Possess exceptional communication, stakeholder management, and client engagement skills.