Digital Quality Transformation - Senior Consultant - Life Sciences (QMS) Join to apply for the Digital Quality Transformation - Senior Consultant - Life Sciences (QMS) role at EY . Location: Multiple US cities including New York, Stamford, Boston, and others. At EY, we’re committed to shaping your future with confidence. We help you succeed in a diverse, globally connected environment and build a better working world. Our Life Sciences team advises clients in biotech, pharma, medical devices, and medtech sectors on risk management, performance, and patient safety. We focus on developing and implementing systems governed by FDA and other global regulations, such as: Quality Management Systems (complaints, CAPAs, deviations, change control, audits, supplier quality) Regulatory Affairs (submissions, health registration) Laboratory Information Management Systems Computer Systems Validation (GxP lifecycle) Responsibilities include supporting client projects involving QMS, DMS, Safety, LIMS, and RIM systems, validation lifecycle management, and conducting quality audits. You will work with diverse teams to deliver high-quality services, maintaining long-term client relationships. Travel up to 40% required. Skills include large-scale implementation, project management, risk monitoring, and industry trend awareness. Qualifications: Bachelor's or Master’s in relevant fields, 3+ years in life sciences, experience with regulatory statutes, GxP processes, system validation, risk management, and preferably Veeva Vaults, LIMS, or validation systems. We offer competitive salary ranges, benefits, flexible work arrangements, and a culture of inclusion and innovation. Join us to shape your future with confidence. EY is an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr EY
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