RC - REGULATORY COMPLIANCE - REGULATORY COMPLIANCE - Senior

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. Join us to build an exceptional experience for yourself and a better working world for all.

EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – LIMS Consultant - Senior

As part of our EY-ER- Regulatory Compliance team, you will understand clients' business needs and deliver solutions following EY guidelines & methodologies. You will establish, maintain, and strengthen internal and external relationships, drive projects to high-quality completion, achieve operational efficiency, proactively identify risks, and lead internal initiatives.

The opportunity

We seek a Senior with expertise in LIMS Implementations & Configurations for the Life Sciences industries to join our team. This is a fantastic opportunity to be part of a leading firm and contribute to the growth of our emerging service offerings.

Your key responsibilities

• Gather and document LIMS requirements by working closely with stakeholders, laboratory personnel, and IT teams.
• Analyze business requirements related to LIMS functionality and enhancements.
• Analyze laboratory workflows and recommend LIMS solutions.
• Translate business needs into system specifications and configurations.
• Configure, test, and validate LIMS functionalities.
• Conduct impact analysis and risk assessments for LIMS changes.
• Act as a liaison between users and technical teams for effective communication.
• Participate in process mapping and workflow optimization.
• Suggest system enhancements and new features.
• Troubleshoot and resolve LIMS issues.
• Conduct user training and support.
• Ensure LIMS supports laboratory practices and workflows.
• Identify automation opportunities within laboratory operations.
• Master Data Design Configuration
• Convert technical documents into LIMS-compatible data sets.
• Configure master data elements within LIMS.
• Maintain data integrity and version control.
• Implement data changes aligning with regulatory needs.
• Collaborate on data migration and system integration.
• Troubleshoot master data issues.
• Configurations & Customizations
• Develop and support LIMS applications.
• Configure and support various LIMS platforms.
• Integrate LIMS with other enterprise systems.
• Design and optimize databases.
• Develop system interfaces and automation scripts.
• Provide technical support and troubleshooting.
• Collaborate with teams, create documentation, ensure compliance, and stay updated on trends.
• Support change management and vendor interactions.
• Maintain client relationships and contribute to operational improvements.
• Mentor team members and promote teamwork.

Skills and attributes for success

• Strong understanding of laboratory workflows and data integrity.
• Experience with analytical techniques, instrumentation, and standards.
• Proficiency in LIMS software and system integration.
• Experience in system validation, testing, and documentation.
• Knowledge of related enterprise applications and databases.
• Problem-solving, communication, and stakeholder management skills.
• Attention to detail, adaptability, and project management experience.
• Understanding of regulations like GLP, GMP, and ISO standards.

To qualify for the role, you must have

• B.E/B.Tech or postgraduate in Science with 4-8 years of relevant experience.
• Good interpersonal, written, and presentation skills.

Ideally, you’ll also have

• Certifications in Information Security, Risk Management, or LIMS administration.
• Certified Scrum Master or similar (preferred).

What we look for

• A team with commercial acumen, technical expertise, and enthusiasm for learning.
• Opportunity to work with a global, multidisciplinary team in a leading firm.

What working at EY offers

We focus on meaningful projects, personal development, and a flexible work environment. We value our employees and support your growth through coaching, development plans, and challenging assignments. Join us to be part of an interdisciplinary environment emphasizing quality and knowledge exchange.

• Support, coaching, and feedback from engaging colleagues.
• Opportunities for skill development and career progression.
• Flexibility to manage your role effectively.

EY | Building a better working world

Our purpose is to create long-term value for clients, people, and society, building trust through assurance, and helping clients grow and transform. We operate in over 150 countries, providing trust through assurance and advisory services across various disciplines.