Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)

About the role

The Life Sciences Risk Consulting Services team at EY focuses on advising biotechnology, pharmaceutical, medical device manufacturers, and medical technology companies on managing risks that impact their performance and patient safety. You will play a crucial role in helping clients identify, manage, and respond to risks, ensuring alignment between risk and business objectives.

Responsibilities

• Implementing Quality Management Systems (QMS), Data Management Systems (DMS), Safety Management Systems (SMS), Laboratory Information Management Systems (LIMS), and Risk Information Management (RIM) systems.
• Developing and executing Quality and Regulatory processes.
• Performing computer systems validation activities following GxP system development lifecycle.
• Managing Quality audits within the QMS area.
• Working on teams to consistently deliver quality client services.

Requirements

• 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.
• Three or more years of Life Sciences work experience, including experience with Life Science regulatory statutes, GxP business processes, or system validations, risk management, or compliance programs.

Qualifications

• Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

Skills and Attributes

• Strong delivery capability.
• Ability to monitor progress, manage risk, and keep stakeholders informed.
• Knowledge of current industry trends relevant to the client's business.
• Effective teamwork and collaboration with diverse skill sets and backgrounds.
• Innovative and inclusive team-oriented work environment.
• Deep technical capabilities and professional knowledge.

Pay

$93,600 to $154,500 annually.

Schedule

Full-time employment with up to 40% travel required.