RC-REGULATORY COMPLIANCE-Lab Digitisation - CA-Labware-Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Manager – LABS – LIMS Configuration 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 Configure and customize LIMS platforms (LabWare, Benchling, STARLIMS) to support end-to-end laboratory workflows including sample lifecycle management, testing, stability studies, and reporting. Design and implement master data, workflows, and business rules (e.g., specifications, test methods, instruments, calculations) aligned with GxP requirements and regulatory standards. Develop integrations and data interfaces between LIMS and enterprise systems (e.g., CDS, ELN, ERP, MES) using APIs, middleware, or flat-file exchanges to enable seamless data flow. Support validation and compliance activities by preparing configuration documentation, executing IQ/OQ/PQ, and ensuring adherence to 21 CFR Part 11, ALCOA+ data integrity principles. Troubleshoot and optimize system performance by resolving configuration issues, enhancing usability, and driving continuous improvement initiatives across laboratory operations. 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