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

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Manager – LABS – LIMS Configuration

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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 platforms
• Ensure data integrity, traceability, and compliance with GxP, 21 CFR Part 11, Annex 11, and internal SOPs
• Guide clients through CSV / CSA / risk‑based 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 knowledge‑transfer 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 design, and practice development for Digital Lab offerings
• Guide decisions on vendor coordination, system design tradeoffs, and implementation timelines
• Apply structured and analytical thinking to improve delivery efficiency and client outcomes.

Other Responsibilities

• Contribute to business development, proposals, and client presentations related to Digital Lab initiatives
• Support inspection readiness, mock audits, and CAPA activities
• Stay current with regulatory expectations, industry trends, and emerging digital lab technologies
• Promote adoption of automation, analytics, and innovation within laboratory operations
• Collaborate with Quality, IT, Regulatory, and Manufacturing teams to deliver integrated solutions
• Uphold EY’s standards for ethics, quality, and compliance.

Skills and attributes for success

• Strong understanding of regulated laboratory environments and quality‑driven operations
• Ability to identify process gaps, operational risks, and improvement opportunities
• Structured and analytical approach to problem‑solving and decision‑making
• Strong stakeholder and client‑management skills
• Ability to work effectively in global, cross‑functional teams
• Leadership mindset with the ability to guide teams and influence outcomes
• Consulting orientation balancing compliance, pragmatism, and delivery excellence
• High attention to detail with awareness of the broader business and compliance context
• Openness to digital transformation and innovation.

To qualify for the role, you must have

• 8–12 years of experience in Digital Lab, LIMS, ELN, LES, or regulated laboratory systems
• Proven experience leading or supporting digital lab implementations, upgrades, or validation initiatives
• Experience working in regulated GxP environments, supporting audits and inspections
• Demonstrated experience managing teams, vendors, or complex stakeholders
• Strong documentation discipline and familiarity with controlled quality systems
• Ability to operate at a managerial level, balancing delivery and people leadership

Ideally, you’ll also have

• Certifications such as Labware Configuration, Sample Manager developer, Computer System Validation (CSV/CSA), or Project Management Professional (PMP).
• Experience with global or multi-site digital laboratory implementations, upgrades, and inspection-readiness activities.
• Familiarity with emerging technologies in laboratory operations, including automation, analytics, and AI/ML-enabled solutions.
• Knowledge of data integrity principles, electronic records and signatures, and structured laboratory data management.
• Experience with industry-leading digital lab platforms such as LabWare, SampleManager, STARLIMS, Benchling, or equivalent systems.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you