Risk Consulting - Enterprise Risk - Sr Manager - Life Sciences

Risk Consulting – Enterprise Risk - Life Sciences – Senior Manager

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.

The opportunity

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.

Your key responsibilities

As a Senior Manager, you will have accountability for engagement leadership, client relationships, and people development, including:

• 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.

Skills and attributes for success

• 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

To qualify for the role, you must have

• 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 workstreams 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

Ideally, you’ll also have

• Experience supporting global Life Sciences organizations across R&D, manufacturing, and supply chain
• Prior responsibility for sales, account growth, or offering development
• Experience mentoring managers and building future leaders

• Willingness to travel up to 40%, based on client needs

What we look for

We’re looking for senior leaders who can help Life Sciences organizations modernize laboratories, strengthen quality capabilities, and navigate regulatory complexity—all while enabling innovation and measurable business value. If you thrive at the intersection of strategy, technology, and compliance, this role offers the opportunity to make a lasting impact.