RC-REGULATORY COMPLIANCE-Labware - BA-Manager

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 – LABS – Business Analyst At EY, we’re all in to shape your future with confidence.   We’ll 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.   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 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 EY’s 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