Advance your career in regulatory compliance and digital laboratory transformation with EY's Enterprise Risk team. This Manager role focuses on leading GxP-compliant digital initiatives, leveraging expertise in LIMS, ELN, and LES. You'll translate regulatory strategies into scalable solutions for global clients, ensuring data integrity and operational excellence.

Join a dynamic, globally connected team dedicated to shaping your future with confidence. EY offers a supportive environment, opportunities for continuous learning, and the chance to build a career as unique as you are.

Lead digital lab initiatives, including LIMS, ELN, and LES implementations in regulated GxP environments. Configure LIMS platforms (LabWare, Benchling, STARLIMS) to support laboratory workflows and configure master data, workflows, and business rules aligned with GxP requirements.

Develop integrations between LIMS and enterprise systems. Support validation activities, including IQ/OQ/PQ, and ensure adherence to 21 CFR Part 11 and ALCOA+ principles. Troubleshoot system performance and drive continuous improvement. Partner with clients to translate business and compliance needs into digital solutions.

Guide clients through CSV/CSA/risk-based validation activities. Support audits and identify opportunities for process harmonization and digital enablement. Lead, coach, and mentor digital lab consultants, manage work allocation, and foster a culture of quality.

A seasoned Manager with 8-12 years of experience in Digital Lab, LIMS, ELN, LES, or regulated laboratory systems is required. Proven experience leading digital lab implementations, upgrades, or validation initiatives within regulated GxP environments is essential. Demonstrated ability to manage teams, vendors, or complex stakeholders, coupled with strong documentation discipline and familiarity with controlled quality systems, is crucial.

Candidates must possess a strong understanding of regulated laboratory environments and quality-driven operations, with an analytical approach to problem-solving and decision-making. Excellent stakeholder and client management skills are vital, as is the ability to work effectively in global, cross-functional teams. A leadership mindset and consulting orientation, balancing compliance, pragmatism, and delivery excellence, are key attributes for success.