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Manager - Regulatory Compliance, Lab Digitisation
EYManager leading regulatory compliance and digital laboratory initiatives at EY. Overseeing LIMS, ELN, and LES implementations in GxP environments with a focus on quality and strategic execution.
Tech Stack
Tools & technologiesERPPMP
About the role
Key responsibilities & impact- 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
- 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
- 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
LIMSELNLESAPIsmiddlewaredata migrationCSVCSAGxPdata integrity
Soft Skills
leadershipteam managementdocumentation disciplineclient collaborationcontinuous improvementcoachingmentoringcommunicationproblem-solvingstakeholder management
Certifications
Labware ConfigurationSample Manager developerComputer System Validation (CSV/CSA)Project Management Professional (PMP)