.EY - GDS Consulting - Enterprise Risk (ER) - Regulatory Compliance - Senior 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 senior, you will 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 the EY senior management team, and lead internal initiatives. The opportunity We're looking for a Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offerings. Your key responsibilities Actively contribute to the IT applications project management initiatives that include Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System, etc. Troubleshoot IT application-related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies are in line with Life Cycle Approach. Perform Software classification, IT risk assessment, and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement. Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapt methods & practices to fit operational team needs & contribute to thought leadership documents. Demonstrate teamwork by working with cross-functional teams across service lines in completing the deliverables within the timelines. Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives