Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences

Location:

Arlington, Baltimore, Boston, Chantilly, Charleston, Chicago, EY-Pitts, Hartford, Hoboken, McLean, New York, Philadelphia, Providence, Stamford, Washington DC

At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.

Our clients operate in a complex and highly regulated Life Sciences environment where innovation, operational excellence, and patient safety are equally critical. EY’s Life Sciences Risk Consulting team supports biotechnology, pharmaceutical, medical device, and medical technology organizations as they modernize laboratory and quality operations while managing regulatory risk and accelerating business performance.

As a Senior Manager within EY’s Life Sciences Transformation practice, you will serve as a strategic leader and trusted advisor, helping clients shape and execute large‑scale laboratory and quality transformation programs across R&D, manufacturing, and commercial operations. You will lead multi‑workstream engagements, influence executive stakeholders, and guide clients through complex regulatory and technology‑enabled change.

This role balances laboratory transformation leadership with quality and regulatory enablement, ensuring innovation is achieved without compromising compliance in FDA‑ and globally regulated environments.

Key focus areas include leading laboratory transformation programs, such as digital lab modernization, enterprise LIMS implementations, operating model and process redesign, and integration of laboratory platforms across the product lifecycle—supported by quality, regulatory, and validation capabilities that enable compliant and scalable operations.

• Leading enterprise‑scale laboratory transformation initiatives, including digital lab modernization, LIMS implementations, and operating model redesign across R&D, quality control, and manufacturing.
• Acting as a senior advisor to Life Sciences clients, shaping strategy and guiding complex, technology‑enabled change in regulated environments.
• Providing executive oversight across laboratory, quality, and compliance programs—driving delivery excellence, regulatory confidence, and team development.
• Driving business development, including identifying opportunities, shaping proposals, and contributing to go‑to‑market offerings within Life Sciences Transformation.
• Leading, mentoring, and developing managers and teams, fostering a high‑performance, inclusive, and collaborative culture.
• Contributing to EY’s market presence, including the development of thought leadership, points of view, and leading practices related to laboratory and quality transformation.

• Demonstrated ability to lead enterprise‑scale transformation initiatives in regulated Life Sciences environments
• Deep understanding of laboratory operations, digital lab technologies, and quality/regulatory frameworks
• Strong executive communication and stakeholder management skills
• Proven experience managing financial performance, delivery quality, and risk across multiple engagements
• Ability to balance innovation and compliance in complex regulatory settings
• Passion for developing talent and building high‑performing teams
• Intellectual curiosity and commitment to staying ahead of industry trends in Life Sciences, laboratory innovation, and regulatory compliance

• A bachelor’s or master’s degree in Life Sciences, Engineering, Computer Science, or a related field
• 10+ years of Life Sciences experience, including significant work in laboratory operations, quality systems, regulatory compliance, or GxP‑regulated environments
• 5+ years of experience leading complex client engagements, programs, or work streams in consulting or industry
• Extensive experience with laboratory systems (e.g., LIMS) and/or quality and regulatory platforms
  
  Strong background in computer systems validation, data integrity, and regulatory compliance