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.

Find out if this opportunity is a good fit by reading all of the information that follows below.

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.

We leverage best practices and a high degree of business acumen that has been compiled over years of experience to ensure the highest level of execution and satisfaction for our clients.

At EY, we use the best technology to deliver solutions to meet our client goals.

We are looking for a manager that can drive innovation and excellence in our lab transformation strategy and lab systems implementation team within the Life Sciences sector.

The ideal candidate will bring deep expertise in lab operations and the underlying technical capability of the systems that support lab operations (including LIMS, ELN, LES, etc.

a proven track record of delivering LIMS implementations and modernization of lab operations, and a passion for leveraging technology to drive significant business outcomes for our clients.

This is a high growth, high visibility area with plenty of opportunities to enhance your skillset and build your career.

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.

The Digital Lab Transformation Manager is responsible for helping our clients design the operating model of their digital labs with operational excellence.

This role helps our clients to design processes for their labs to deliver against their overall Digital Transformation strategy and to design and deliver clear data strategies to move clients to a more agile processes in their operating models.

Your role encompasses formulating technical solution designs and leading conversations for our Life Sciences clients. Your primary objectives will include understanding client needs, architecting transformative solutions in partnership with the process owners, and simplifying complex implementations.

In addition, you will lead delivery in the following technical areas for the solution :

• 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.
• You will also be expected to work on teams to consistently deliver quality client services by demonstrating in-depth technical capabilities and professional knowledge and maintaining long-term client relationships.

Skills and attributes for success

To thrive in this role, you will need a strong capability in risk management and a deep understanding of governance and compliance disciplines.

Your ability to lead workstream delivery and track project status will be key to our collective success.

• Billable to external client.
• Leads workstream delivery.
• Tracks deliverable completion and project status.
• Performing large-scale implementations with consistent high-quality delivery.
• 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.
• Demonstrating deep technical capabilities and professional knowledge.

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.
• Technical Skills Board Capability Analysis and Role Definition.
• Board Level Reporting.
• Board Metrics Design and Communication.
• Board Training Design.
• Client and Sector Understanding.
• Deep Sector Expertise.
• Financial Systems Understanding.
• Impact Measurement.
• 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.

A global mindset and learning agility will set you apart as a candidate who can drive the success of our Governance, Risk, and Compliance practice.

We are interested in passionate leaders with strong delivery capability and a strong desire to stay on top of trends in the life sciences industry.

If you desire to help businesses drive measurable value while serving patients, then this role is for you.

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.

Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills, and geography.

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.

Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances.

You’ll also be granted time off for designated EY Paid Holidays, Winter / Summer breaks, Personal / Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being.

• Continuous learning : You’ll develop the mindset and skills to navigate whatever comes next.
• Success as defined by you : We’ll provide the tools and flexibility, so you can make a meaningful impact, your way.
• Transformative leadership : We’ll give you the insights, coaching, and confidence to be the leader the world needs.
• Diverse and inclusive culture : You’ll be embraced for who you are and empowered to use your voice to help others find theirs.

EY accepts applications for this position on an on-going basis.

If you can demonstrate that you meet the criteria above, please contact us as soon as possible.

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.

Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate.

Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

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, including arrest and conviction records, in accordance with applicable law.

EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities.

If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at @ey.com

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