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

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

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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.

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 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
• 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 / 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 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 EYs standards for ethics quality and compliance.

Skills and attributes for success

• Strong understanding of regulated laboratory environments and qualitydriven operations
• Ability to identify process gaps operational risks and improvement opportunities
• Structured and analytical approach to problemsolving and decisionmaking
• Strong stakeholder and clientmanagement skills
• Ability to work effectively in global crossfunctional 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

• 812 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 youll 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 were dedicated to helping our clients from startups 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 thats right for you