Risk Consulting, Life Sciences Regulatory Compliance, Senior Manager

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

The opportunity

As a Senior Manager in Governance, Risk, and Compliance, you will be at the forefront of implementing enterprise-wide frameworks that enhance processes, including automation and optimization of control points. Your role will involve liaising with operational risk teams, analyzing gaps, and ensuring compliance with regulatory frameworks.

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.

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 lead processes, solutions, and/or projects with a focus on quality and robust risk management. You will drive continuous improvement and innovation through research, analysis, and the application of best practices. You will oversee a team of professionals, supervising complex technical initiatives, and applying your expertise to lead and interpret internal and external issues. Travel will be required (up to 70%), and you will have daily interactions with external clients, leading work sessions and steering workstreams.

The Digital Lab Transformation Senior 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:

Lead workstream deliveries and manage engagement economics

Participate in resource planning and budgeting

Identify sales opportunities and lead RFP responses

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 excel in this role, you will need a combination of technical and business skills, critical thinking, and the ability to solve complex problems. You should be adept at risk identification and mitigation, and have a strong understanding of financial systems and policy setting.

Board capability analysis

Regulatory change management

Sustainability and long-term planning

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

A 4-year bachelor’s degree or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least ten years of related work experience.

Typically, 8 years of relevant experience

Capability analysis and role definition at the board level

Proficiency in board-level reporting, metrics design, and communication

Knowledge of financial systems, impact measurement, and organizational control model design

Skills in outsourcing, co-sourcing models, policy setting, and regulatory change management

Experience in implementing LabWare or LabVantage LIMS systems

Excellent leadership, communication, and project management skills.

Ideally, you’ll also have

Advanced problem-solving and critical thinking skills

Strong leadership and team management abilities

Excellent communication and stakeholder engagement skills

10 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 the ability to lead with integrity, think analytically, and drive innovation. You should be a strategic thinker with a passion for excellence and a commitment to fostering an inclusive environment. If you are eager 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 $123,600 to $282,300. The salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $148,300 to $320,800. 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 ssc.customersupport@ey.com