EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, Austin, Texas, us, 78716
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Digital QualityTransformation - 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 Life Sciences team advises clients in the Life Sciences sector on strategic decisions to address risks impacting an organization’s performance and patient safety. Overview
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team aligns risk and business objectives from strategy to execution, and improves 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 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) We also work on projects to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing cGMP and 21 CFR Part 11 regulations to determine impact on risk exposure. 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 delivery roles. 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 You will work on teams to deliver quality client services by demonstrating technical capabilities and maintaining long-term client relationships. This is a full-time role with travel required up to 40%. Skills And Attributes For Success
Performing large-scale implementations with high-quality delivery Driving high-quality work products within expected timeframes and budgets Ability to monitor progress, manage risk, and keep stakeholders informed Staying abreast of current industry trends relevant to the client’s business Effectively working on diverse teams and fostering an innovative, inclusive 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 experience, including working with Life Science regulatory statutes, GxP 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 desire to stay on top of trends in the life sciences industry. If you have a passion for helping businesses drive measurable value while serving patients, this role is for you. What We Offer You
EY will develop you with future-focused skills and equip you with world-class experiences. We offer a flexible environment and a diverse, inclusive culture of globally connected teams. Comprehensive compensation and benefits package with base salary ranges: US-wide $93,600 to $154,500; NYC Metro/WA/CA ranges $112,400 to $175,600. Salaries depend on education, experience, knowledge, skills, and geography. Total Rewards include medical/dental coverage, pension and 401(k), and paid time off. Hybrid work model (most client-facing roles: 40-60% in person during engagements) Flexible vacation policy and designated leave for holidays, personal/family care, and other supports Are you ready to shape your future with confidence? Apply today. EY focuses on equal employment opportunities and provides accommodation to qualified individuals with disabilities. For details, see EY’s accessibility information. Equal Opportunity and Accessibility
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. EY is committed to providing reasonable accommodation to qualified individuals with disabilities, including veterans with disabilities. For assistance applying online or accommodation requests, contact EY’s Talent Shared Services.
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Digital QualityTransformation - 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 Life Sciences team advises clients in the Life Sciences sector on strategic decisions to address risks impacting an organization’s performance and patient safety. Overview
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team aligns risk and business objectives from strategy to execution, and improves 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 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) We also work on projects to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing cGMP and 21 CFR Part 11 regulations to determine impact on risk exposure. 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 delivery roles. 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 You will work on teams to deliver quality client services by demonstrating technical capabilities and maintaining long-term client relationships. This is a full-time role with travel required up to 40%. Skills And Attributes For Success
Performing large-scale implementations with high-quality delivery Driving high-quality work products within expected timeframes and budgets Ability to monitor progress, manage risk, and keep stakeholders informed Staying abreast of current industry trends relevant to the client’s business Effectively working on diverse teams and fostering an innovative, inclusive 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 experience, including working with Life Science regulatory statutes, GxP 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 desire to stay on top of trends in the life sciences industry. If you have a passion for helping businesses drive measurable value while serving patients, this role is for you. What We Offer You
EY will develop you with future-focused skills and equip you with world-class experiences. We offer a flexible environment and a diverse, inclusive culture of globally connected teams. Comprehensive compensation and benefits package with base salary ranges: US-wide $93,600 to $154,500; NYC Metro/WA/CA ranges $112,400 to $175,600. Salaries depend on education, experience, knowledge, skills, and geography. Total Rewards include medical/dental coverage, pension and 401(k), and paid time off. Hybrid work model (most client-facing roles: 40-60% in person during engagements) Flexible vacation policy and designated leave for holidays, personal/family care, and other supports Are you ready to shape your future with confidence? Apply today. EY focuses on equal employment opportunities and provides accommodation to qualified individuals with disabilities. For details, see EY’s accessibility information. Equal Opportunity and Accessibility
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. EY is committed to providing reasonable accommodation to qualified individuals with disabilities, including veterans with disabilities. For assistance applying online or accommodation requests, contact EY’s Talent Shared Services.
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