The Digital Quality Transformation - Senior Consultant role at EY focuses on advising clients in the Life Sciences sector, particularly in managing risks and enhancing performance. The team works with biotechnology, pharmaceutical, and medical device manufacturers to implement Quality Management Systems and ensure compliance with regulatory standards. This position requires collaboration with clients to develop business processes and systems that align with FDA regulations. The consultant will play a key role in delivering high-quality services and maintaining long-term client 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 the Life Sciences sector.
• 3+ years of experience with Life Science regulatory statutes, GxP business processes, or system validations.
• Experience in implementing Veeva Vaults, LIMS, or Validation Lifecycle Management Systems is preferred.

• Support client engagement teams in delivering projects in the life sciences domain.
• Implement Quality Management Systems, Document Management Systems, and Laboratory Information Management Systems.
• Design and execute QMS and Regulatory processes.
• Perform computer systems validation activities and quality audits of client processes.
• Monitor project progress, manage risks, and keep stakeholders informed about outcomes.

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