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

- Robust understanding of regulated laboratory environments and quality driven operations
- Ability to identify process gaps, operational risks, and improvement opportunities

📌 RC-REGULATORY COMPLIANCE-Lab Digitisation - CA-Labware-Manager (Bengaluru)
🏢 EY
📍 Bengaluru