Risk consulting life sciences regulatory compliance manager

Risk Consulting Life Sciences Regulatory Compliance Manager

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better. Join us and build an exceptional experience for yourself, and a better working world for all.

The exceptional EY experience. It's yours to build.

EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities.

Risk - Governance, Risk and Compliance - Manager, Life Sciences: This position can be anywhere in the country.

The Opportunity

As a Manager in Governance, Risk, and Compliance, you will have the opportunity to implement enterprise governance and compliance frameworks, identify control points in need of improvement, optimization, or automation, and liaise with operational risk teams to enhance compliance and operational efficiency. You will support the selection of compliance software and analyze data to guide automated compliance processes.

Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team designs and implements solutions in the Life Sciences sector to address risks impacting their organization’s performance and impacting patient safety.

The Life Sciences Risk Consulting team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry, enabling our clients to leverage the newest technologies securely and at scale.

Your Key Responsibilities

In this pivotal role, you will be responsible for managing and delivering one or more processes, solutions, and/or projects with a focus on quality and effective risk management. Continuous process improvement and the identification of innovative solutions through research and analysis will be part of your remit. You will guide others using your depth of expertise and interpret internal/external issues to recommend quality solutions. Meeting performance objectives and metrics set locally will be crucial to your success. Travel (up to 70%) may be required as needed by external clients.

• Develop solutions to complex problems and recommend policy changes
• Exercise judgment in selecting methods and evaluation criteria for obtaining results
• Manage engagement economics and resource planning
• Collaborate with the clients to oversee program management activities related to Digital Lab Transformations
• Provide strategic expertise on business case and transformation strategies
• Help the client to determine financial plan & budgeting to help the organization optimize costs with Digital Labs
• Lead a diverse team of professionals, responsible for coaching, leadership, and career development of team members.
• Translate complex requirements into actionable insights for C-suite and Director-level stakeholders.
• Serve as a technical authority on LIMS architecture, championing the change within our clients.
• Orchestrate the execution of Digital Lab Transformation projects with precision, ensuring adherence to technical specifications, deadlines, and quality benchmarks.
• Maintain an expert-level understanding of industry-specific trends and technology advancements to inform strategic solution architecture within the digital labs space.

Skills and Attributes for Success

• Strong capability in risk management and a deep understanding of governance and compliance disciplines.
• Ability to lead workstream delivery and track project status.
• Billable to external client
• Tracks deliverable completion and project status
• Driving high-quality work products within expected timeframes and on budget
• Ability to monitor progress, manage risk, and ensure key stakeholders are kept informed about progress and expected outcomes
• Staying abreast of current industry trends relevant to the client’s business
• Effectively working on teams with diverse skills and backgrounds
• Fostering an innovative and inclusive team-oriented work environment

To Qualify for the Role, You Must Have

• Bachelor’s or master’s degree in computer science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field.
• 6+ years relevant experience.
• Experience in implementing LabWare or LabVantage LIMS systems
• Excellent leadership, communication, and project management skills.

Ideally, You’ll Also Have

• Proven experience in managing change and driving outcomes
• Strong skills in complex problem-solving and critical thinking
• Excellent communication skills and a global mindset
• 8+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or compliance programs or integration of risk management functions.

What We Look For

We are seeking top performers who demonstrate a blend of talents and skills, including client trust and value, commercial astuteness, and a strong ability to communicate with impact. You should possess a knack for solving complex problems, have a digital fluency, and be adept at leading teams and managing change.

What We Offer

We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $107,000 to $196,100. The salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $128,400 to $222,900.

In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.

Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.

EY accepts applications for this position on an ongoing basis.

EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets.

For those living in California, please click here for additional information.

EY is an equal opportunity, affirmative action employer providing equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis.