EY
Risk consulting life sciences regulatory compliance senior manager
EY, Honolulu, Hawaii, United States, 96814
Risk Consulting Life Sciences Regulatory Compliance Senior 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.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.Your key responsibilities:Lead processes, solutions, and/or projects with a focus on quality and robust risk management.Drive continuous improvement and innovation through research, analysis, and the application of best practices.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.Help clients design the operating model of their digital labs with operational excellence.Formulate technical solution designs and lead conversations for our Life Sciences clients.Lead workstream deliveries and manage engagement economics.Participate in resource planning and budgeting.Identify sales opportunities and lead RFP responses.Collaborate with clients to oversee program management activities related to Digital Lab Transformations.Provide strategic expertise on business case and transformation strategies.Help clients determine financial plans and budgeting to optimize costs with Digital Labs.Lead a diverse team of professionals and coach team members.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.Proficiency in board-level reporting, metrics design, and communication.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.We are seeking top performers who demonstrate the ability to lead with integrity, think analytically, and drive innovation. If you are eager to help businesses drive measurable value while serving patients, then this role is for you.What 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.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.
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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.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.Your key responsibilities:Lead processes, solutions, and/or projects with a focus on quality and robust risk management.Drive continuous improvement and innovation through research, analysis, and the application of best practices.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.Help clients design the operating model of their digital labs with operational excellence.Formulate technical solution designs and lead conversations for our Life Sciences clients.Lead workstream deliveries and manage engagement economics.Participate in resource planning and budgeting.Identify sales opportunities and lead RFP responses.Collaborate with clients to oversee program management activities related to Digital Lab Transformations.Provide strategic expertise on business case and transformation strategies.Help clients determine financial plans and budgeting to optimize costs with Digital Labs.Lead a diverse team of professionals and coach team members.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.Proficiency in board-level reporting, metrics design, and communication.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.We are seeking top performers who demonstrate the ability to lead with integrity, think analytically, and drive innovation. If you are eager to help businesses drive measurable value while serving patients, then this role is for you.What 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.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.
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