RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance Senior- Kneat Developer (Life Sciences IT Systems)

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 looking for an Kneat Developer support the design, configuration, and implementation of Kneat Gx for validation and quality documentation management in regulated environments.

In this role, you will configure Kneat Gx solutions using out-of-the-box capabilities, develop advanced configurations, support system integrations, and contribute to Computer System Validation (CSV/CSA) activities. You will collaborate closely with cross-functional client and EY teams to enable compliant, efficient, and scalable validation processes.

Role Overview

As a Kneat Developer, you will translate business and validation requirements into functional configurations within the Kneat Gx platform. You will lead requirements-gathering workshops and design sessions with cross-functional stakeholders, while supporting system implementation, qualification, and ongoing enhancements. You will ensure that all solutions comply with global regulatory standards, including GxP, 21 CFR Part 11, and Annex 11. In this role, you will collaborate closely with Validation, Quality, Manufacturing, Clinical, Regulatory, and IT teams to enable successful digital validation transformations across the organization.

Your key responsibilities

• Collaborate with business and technical stakeholders to gather, analyze, and document requirements
• Configure Kneat Gx applications, including document lifecycles, workflows, templates, and permissions
• Design and maintain validation content such as protocols, test scripts, and traceability
• Support Agile delivery teams through iterative configuration and continuous improvement
• Perform unit testing and support IQ/OQ/PQ execution for Kneat Gx solutions
• Peer review configurations and validation deliverables
• Manage solution promotions across environments in line with SDLC and change control processes
• Create and maintain system documentation, configuration specifications, and SOPs
• Support data migration, reporting, and integration activities where applicable
• Provide user training, knowledge transfer, and go-live support
• Troubleshoot system issues and support root cause analysis and impact assessments
• Stay current with Kneat Gx product updates, validation trends, and regulatory expectations

Qualifications:

• Bachelor’s degree in computer science, Software Engineering, Information Technology, Life Sciences, or a related field.
• Strong understanding of validation systems and digital quality platforms, with hands-on experience configuring Kneat Gx.

Must-Have Skills & Attributes

• Experience translating business and validation requirements into configurable Kneat Gx solutions using out-of-the-box functionality.
• 5+ years of proven experience configuring Kneat Gx workflows, lifecycles, templates, and document structures.
• Strong analytical and problem-solving skills, with the ability to assess validation impacts and system dependencies.
• Experience supporting system implementation, qualification, and ongoing enhancements in regulated environments.
• Knowledge of GxP regulations, including 21 CFR Part 11 and EU Annex 11, and their application within Kneat Gx.
• Experience supporting IQ/OQ/PQ and/or CSA-based validation approaches using Kneat Gx.
• Hands-on experience with:
• User roles, permissions, and access controls within Kneat Gx
• Configuration of review, approval, and execution workflows
• Template management and reuse for validation documentation
• Experience with data migration into Kneat Gx, including best practices for data integrity, traceability, and audit readiness.
• Familiarity with integrations or data exchange between Kneat Gx and other enterprise systems (e.g., QMS, LIMS, MES, ERP).
• Ability to work independently, manage multiple priorities, and deliver within Agile or iterative delivery models.
• Strong communication, documentation, and cross-functional collaboration skills.

Good-to-Have Skills & Attributes

• Kneat Gx certification (User, Power User, or Configuration).
• Experience working in consulting or client-facing roles within Life Sciences.
• Exposure to regulatory inspections and audit support involving digital validation 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