Join EY and build a career that's as unique as you are. We are seeking a Senior Regulatory Compliance professional with expertise in LIMS implementations and configurations for the Life Sciences industry. This role offers a significant opportunity to contribute to the growth of an emerging service offering within a leading global firm.

As a Senior member of our Regulatory Compliance team, you will be instrumental in understanding client business needs and delivering tailored solutions. You'll focus on establishing and strengthening relationships, ensuring high-quality deliverables, driving operational efficiency, and proactively managing risks. This position is perfect for individuals eager to leverage their technical skills in a dynamic consulting environment.

EY is dedicated to fostering a culture of continuous learning and development, providing support, coaching, and opportunities to grow your career. You will be empowered to take ownership of your development and contribute to meaningful projects.

Key responsibilities include collaborating with stakeholders to gather and document LIMS requirements, analyzing laboratory workflows, and translating business needs into functional specifications. You will configure, test, and validate LIMS functionalities, conduct impact and risk assessments, and serve as a liaison between business users and technical teams.

Further responsibilities involve master data configuration, including test methods, sample types, and specifications, ensuring data integrity and version control. You will develop, customize, and support LIMS applications, integrate LIMS with other enterprise systems, and provide technical support. Compliance with industry standards like CGxP and FDA 21 CFR Part 11 is essential.

Additional duties include creating system documentation, conducting user training, staying updated on LIMS technologies, and ensuring system security. Demonstrating teamwork, maintaining a strong client focus, and contributing to operational improvements are also vital aspects of this role.

To excel in this role, you must possess a Bachelor's degree in Computer Science, Life Sciences, Chemistry, Information Technology, or a related field, or a Postgraduate degree in Science (preferably Chemistry/Biochemistry). A minimum of 5-8 years of experience is required, ideally with Big 4 or multinational Regulatory Compliance companies, or leading Life Sciences/Pharmaceutical industries.

Essential skills include a strong understanding of laboratory workflows, sample lifecycle management, and data integrity. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards such as GLP, GMP, and ISO 17025 is expected. Proficiency in LIMS software (e.g., LabWare, LabVantage) and system integration knowledge is crucial.

Ideal candidates will have prior experience as a Business Analyst, System Administrator, or Master Data Manager with LIMS. Hands-on experience in master data configuration, system validation, and testing is necessary. An understanding of relational databases and SQL queries is also beneficial. Excellent communication, problem-solving, and analytical skills are paramount for success.