RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –LIMS BA/Configuration- Senior

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 senior 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 a highly experienced and detail-oriented LIMS Business Analyst / Configuration Specialist to lead and support the design, configuration, and implementation of Laboratory Information Management Systems (LIMS) within GxP-regulated environments.

The ideal candidate will bridge business and technology by translating laboratory and quality requirements into compliant, scalable LIMS solutions, ensuring alignment with global regulatory standards (FDA, EMA, MHRA). This role supports system implementations and enhancements across the pharmaceutical lifecycle and involves client engagement, business process transformation, and operational excellence initiatives.

Your Key Responsibilities

• Act as a Lead LIMS Business Analyst, working with laboratory, quality, manufacturing, and IT stakeholders to elicit, analyze, and document business, functional, and regulatory requirements.
• Translate laboratory workflows and business needs into LIMS functional designs and configuration specifications, ensuring alignment with GxP and data integrity requirements.
• Lead LIMS configuration activities, including test methods, specifications, sample lifecycle, stability studies, calculations, workflows, user roles, permissions, and reporting.
• Perform business process mapping, gap analysis, and impact assessments to support LIMS implementations, enhancements, and global harmonization initiatives.
• Collaborate with validation and quality teams to ensure LIMS configurations are compliant with GAMP 5, SDLC, and risk-based validation approaches.
• Support and review URS, FRS, Configuration Specifications, and Traceability Matrices, ensuring clear linkage between business requirements, system configuration, and testing.
• Support data migration and integration initiatives between LIMS and enterprise systems such as SAP (ERP), MES, ELN, QMS, and document management platforms.
• Partner with technical teams to define and validate interfaces, data flows, and master data models across integrated systems.
• Participate in system testing activities, including functional testing, UAT support, and review of OQ/PQ execution results.
• Troubleshoot LIMS functional and configuration-related issues, performing root cause analysis and recommending sustainable solutions.
• Support change control, enhancement requests, deviation handling, and CAPA activities related to LIMS configuration and business processes.
• Act as a functional SME for LIMS during internal audits and regulatory inspections.
• Develop and deliver end-user training, SOPs, and job aids to support system adoption and compliance.
• Ensure LIMS remains in a compliant and validated state throughout its operational lifecycle, including upgrades and periodic reviews.
• Provide mentoring and functional guidance to junior LIMS analysts and configuration specialists.
  
  

Qualifications:

• 5+ years of experience working with LIMS systems in pharmaceutical, biotech, or consulting environments.
• Strong understanding of laboratory operations, quality control, and analytical testing processes.
• Solid knowledge of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11.
• Hands-on experience with one or more LIMS platforms (e.g., LabWare, Empower, StarLIMS, SampleManager, Caliber,MODA, or equivalent).
• Excellent communication, documentation, and stakeholder management skills.
  
  

Must-Have Skills & Attributes

• Strong experience in LIMS Business Analysis, including requirements elicitation, stakeholder workshops, and functional design.
• Hands-on experience in LIMS configuration, including sample management, test definitions, specifications, workflows, calculations, roles, security, and reporting.
• Strong understanding of laboratory operations (QC testing, stability, sample lifecycle, batch release, investigations).
• Proven ability to translate business requirements into system configuration and trace them through validation and testing.
• Solid knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data integrity principles (ALCOA+).
• Experience applying GAMP 5 methodology and SDLC in regulated LIMS implementations.
• Experience authoring and reviewing URS, FRS, Configuration Specifications, and Traceability Matrices.
• Familiarity with LIMS integrations with ERP (SAP), MES, ELN, QMS, and analytical instruments.
• Understanding of electronic records and electronic signatures compliance requirements.
• Experience supporting CSV activities and working closely with validation teams.
• Strong analytical and problem-solving skills to troubleshoot functional and configuration issues.
• Ability to collaborate effectively with cross-functional teams (QC, QA, IT, Manufacturing, Labs).
• Client-facing experience with strong communication and stakeholder management skills.
• Experience supporting change control, deviation, and CAPA processes.
• Proven ability to mentor junior BA/configuration resources and support knowledge transfer.
• Strong teamwork, collaboration, and continuous improvement mindset.
  
  

Good-to-Have Skills & Attributes

• Experience with data migration and master data management
• Understanding of laboratory automation and instrument interfacing
• Exposure to business development activities and client engagement support
• Ability to contribute innovative ideas and best practices for LIMS optimization
• Experience in process optimization and operational efficiency initiatives
• Strategic mindset to align LIMS capabilities with digital lab transformation goals
• High attention to detail with strong analytical thinking
• Adaptability to changing regulatory and business environments
  
  

Ideally, you’ll also have

• Certified Software Quality Engineer (CSQE) or Certified Software Quality Assurance (CSQA)
• Information Security or Risk Management certifications
• Vendor-specific LIMS certifications (e.g., LabWare, StarLIMS, MODA, Empower)
  
  

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
  
  

EY | Building a better working world

EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

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