EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, New York, New York, us, 10261
Overview
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS) role at EY. Location: multiple U.S. cities including Atlanta, Austin, Baltimore, Boston, Charlotte, Chicago, Cleveland, Dallas, Detroit, Pittsburgh, Hartford, Hoboken, Houston, McLean, New York, Philadelphia, Stamford and more. EY is seeking to help clients in the Life Sciences sector address risks impacting performance and 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 help clients identify, manage, and respond to risks while accelerating performance and growth. Work involves aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization. You will develop business processes and design/implement systems governed by the FDA and global regulators. 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) Projects may also cover quality business processes for supply chain, manufacturing, commercial operations and R&D, involving analysis of cGMP and 21 CFR Part 11 regulations to determine impact on risk exposure. Your Key Responsibilities
Support client engagement teams to deliver projects in the life sciences domain. Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in roles such as business process analyst, technical writer, project manager, computer systems validation, and related delivery roles. Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat). Design and execution of QMS and Regulatory processes. Perform computer systems validation activities as part of a service. Perform Quality audits of client processes within the QMS area. You will work on teams to deliver high-quality client services, demonstrate technical capabilities, and maintain long-term client relationships. This is a full-time position with travel up to 40%. Skills And Attributes For Success
Deliver large-scale implementations with high quality Produce high-quality work on time and within budget Monitor progress, manage risk, and communicate with stakeholders Stay current with industry trends relevant to the client Collaborate effectively with diverse teams Foster an innovative and inclusive, team-oriented environment Demonstrate 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 related field and at least three years of related work experience 3+ years of Life Sciences experience, including working with regulatory statutes, GxP processes, 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 look for passionate leaders with strong delivery capability and a desire to stay on top of life sciences trends. If you are motivated to help businesses drive measurable value while serving patients, this role is for you. What We Offer You
EY supports your development with future-focused skills and world-class experiences. We offer a flexible, inclusive culture with globally connected teams. Learn more. Comprehensive compensation and benefits with base salary ranges depending on location; total rewards include medical and dental coverage, pension/401(k), and time-off options. Hybrid model: most client-facing roles require in-person work 40-60% of the time. Flexible vacation policy and designated holiday breaks, personal/family care time, and other leave options. Are you ready to shape your future with confidence? Apply today. EY accepts applications on an ongoing basis. For California applicants, additional information is available. EY focuses on high ethical standards and integrity and expects all candidates to demonstrate these qualities. EY | Building a better working world. EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. EY teams help clients shape the future with confidence and develop answers for today and tomorrow. 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, or any other legally protected basis. EY is committed to providing reasonable accommodation to qualified individuals with disabilities, including veterans. For assistance, please call 1-800-EY-HELP or email ssc.customersupport@ey.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing and Sales Industries
Professional Services
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Digital QualityTransformation - Senior Consultant - Life Sciences (QMS) role at EY. Location: multiple U.S. cities including Atlanta, Austin, Baltimore, Boston, Charlotte, Chicago, Cleveland, Dallas, Detroit, Pittsburgh, Hartford, Hoboken, Houston, McLean, New York, Philadelphia, Stamford and more. EY is seeking to help clients in the Life Sciences sector address risks impacting performance and 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 help clients identify, manage, and respond to risks while accelerating performance and growth. Work involves aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization. You will develop business processes and design/implement systems governed by the FDA and global regulators. 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) Projects may also cover quality business processes for supply chain, manufacturing, commercial operations and R&D, involving analysis of cGMP and 21 CFR Part 11 regulations to determine impact on risk exposure. Your Key Responsibilities
Support client engagement teams to deliver projects in the life sciences domain. Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in roles such as business process analyst, technical writer, project manager, computer systems validation, and related delivery roles. Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat). Design and execution of QMS and Regulatory processes. Perform computer systems validation activities as part of a service. Perform Quality audits of client processes within the QMS area. You will work on teams to deliver high-quality client services, demonstrate technical capabilities, and maintain long-term client relationships. This is a full-time position with travel up to 40%. Skills And Attributes For Success
Deliver large-scale implementations with high quality Produce high-quality work on time and within budget Monitor progress, manage risk, and communicate with stakeholders Stay current with industry trends relevant to the client Collaborate effectively with diverse teams Foster an innovative and inclusive, team-oriented environment Demonstrate 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 related field and at least three years of related work experience 3+ years of Life Sciences experience, including working with regulatory statutes, GxP processes, 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 look for passionate leaders with strong delivery capability and a desire to stay on top of life sciences trends. If you are motivated to help businesses drive measurable value while serving patients, this role is for you. What We Offer You
EY supports your development with future-focused skills and world-class experiences. We offer a flexible, inclusive culture with globally connected teams. Learn more. Comprehensive compensation and benefits with base salary ranges depending on location; total rewards include medical and dental coverage, pension/401(k), and time-off options. Hybrid model: most client-facing roles require in-person work 40-60% of the time. Flexible vacation policy and designated holiday breaks, personal/family care time, and other leave options. Are you ready to shape your future with confidence? Apply today. EY accepts applications on an ongoing basis. For California applicants, additional information is available. EY focuses on high ethical standards and integrity and expects all candidates to demonstrate these qualities. EY | Building a better working world. EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. EY teams help clients shape the future with confidence and develop answers for today and tomorrow. 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, or any other legally protected basis. EY is committed to providing reasonable accommodation to qualified individuals with disabilities, including veterans. For assistance, please call 1-800-EY-HELP or email ssc.customersupport@ey.com. Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing and Sales Industries
Professional Services
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