EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, Stamford, Connecticut, United States, 06925
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Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)
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EY Location: Atlanta, Austin, Baltimore, Boston, Charlotte, Chicago, Cleveland, Dallas, Detroit, Pittsburgh, Hartford, Hoboken, Houston, McLean, New York, New York, Philadelphia, Stamford At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety. The Opportunity
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.) Regulatory Affairs (regulatory submissions, Health Registration Management, etc.) Laboratory Information Management Systems Computer Systems Validation (following a GxP system development lifecycle) Your Key Responsibilities
Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including: Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution. Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat) Design and execution of QMS and Regulatory processes. Performing computer systems validation activities as part of a service. Performing Quality audits of client processes within the QMS area. Skills And Attributes For Success
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 bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least three years of related work experience. 3+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions. Ideally, You’ll Also Have
Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems What We Look For
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. What We Offer You
At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. 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. Join us in our team-led and leader-enabled hybrid model. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. EY Is Committed To Providing Reasonable Accommodation
EY provides 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.
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Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)
role at
EY Location: Atlanta, Austin, Baltimore, Boston, Charlotte, Chicago, Cleveland, Dallas, Detroit, Pittsburgh, Hartford, Hoboken, Houston, McLean, New York, New York, Philadelphia, Stamford At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety. The Opportunity
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally: Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.) Regulatory Affairs (regulatory submissions, Health Registration Management, etc.) Laboratory Information Management Systems Computer Systems Validation (following a GxP system development lifecycle) Your Key Responsibilities
Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including: Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution. Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat) Design and execution of QMS and Regulatory processes. Performing computer systems validation activities as part of a service. Performing Quality audits of client processes within the QMS area. Skills And Attributes For Success
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 bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least three years of related work experience. 3+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions. Ideally, You’ll Also Have
Experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems What We Look For
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. What We Offer You
At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. 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. Join us in our team-led and leader-enabled hybrid model. Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. EY Is Committed To Providing Reasonable Accommodation
EY provides 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.
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