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About the role
At EY, were all in to shape your future with confidence. Well help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager LABS Business Analyst 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 with deep expertise in Laboratory Digitalisation to lead regulatory strategy and IT-enabled transformation initiatives in regulated GxP environments. This role requires strong consulting skills, industry knowledge, and the ability to translate regulatory strategy into scalable, compliant solutions for global clients. Role Overview As a Manager at Regulatory Compliance, you will lead Digital Laboratory initiatives in regulated GxP environments, leveraging your deep expertise in Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Laboratory Execution Systems (LES), and strong consulting capabilities. Your primary responsibility will be to partner with clients to understand their laboratory business needs and translate strategic objectives into integrated, compliant, and practical digital lab solutions. You will play a pivotal role in establishing and nurturing relationships across internal teams and external stakeholders, ensuring alignment with EYs 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 Client Responsibilities Lead and oversee Digital Lab initiatives, including LIMS, ELN, and LES implementations, upgrades, and optimizations in regulated laboratory environments Elicit, analyze, and document business requirements for LIMS implementations/enhancements (LabWare, Benchling, STARLIMS), translating laboratory processes into functional specifications and user stories. Act as the bridge between business and technical teams, ensuring accurate mapping of lab workflows (sample management, testing, stability, reporting) into system configurations and solution designs. Drive process optimization and standardization by identifying gaps, redundancies, and improvement opportunities across laboratory operations and aligning with industry best practices. Support system implementation and validation activities by defining test scenarios, coordinating UAT, ensuring traceability, and maintaining compliance with GxP, 21 CFR Part 11, and data integrity requirements. Facilitate stakeholder engagement and change management through workshops, training, documentation, and user support to drive adoption of LIMS solutions across labs.Partner with clients to understand laboratory operations and translate business and compliance requirements into integrated digital lab solutions and their respective configurations Drive requirements gathering, system configuration, data migration, and integrations across lab systems, instruments, and enterprise platforms Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs Guide clients through CSV / CSA / riskbased validation activities for digital lab systems Support audits, inspections, and regulatory assessments related to laboratory systems Identify opportunities for process harmonization, standardization, and digital enablement across laboratories People Responsibilities Lead, coach, and mentor Digital Lab consultants, validation analysts, and technical team members Manage work allocation across LIMS, ELN, and LES engagements, ensuring quality delivery and adherence to timelines Conduct performance reviews, feedback, and development planning Build and strengthen Digital Lab and laboratory systems capabilities within the team Support hiring, onboarding, training, and knowledgetransfer 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 At
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