The Digital Quality Transformation - Senior Consultant role at EY focuses on advising clients in the Life Sciences sector, particularly in managing risks that impact organizational performance and patient safety. The consultant will work within the Life Sciences Risk Consulting Services team, which specializes in biotechnology, pharmaceuticals, and medical technology. The position involves implementing Quality Management Systems and regulatory processes while ensuring compliance with FDA regulations. This role requires collaboration with diverse teams to deliver high-quality client services and maintain long-term relationships.

• A bachelor's or master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing, or a related field.
• At least three years of related work experience in Life Sciences.
• 3+ years of experience with Life Science regulatory statutes, GxP business processes, or system validations.

• Support client engagement teams to deliver projects in the life sciences domain.
• Implement Quality Management Systems, Document Management Systems, and Laboratory Information Management Systems.
• Perform computer systems validation activities as part of a service.
• Conduct quality audits of client processes within the Quality Management System area.
• Drive high-quality work products within expected timeframes and budgets.

• Ernst & Young (EY) offers a comprehensive and competitive benefits package designed to support the well-being of its employees across various dimensions.