EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, Cleveland, Ohio, us, 44101
Overview
Join to apply for the 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 and help clients in the Life Sciences sector improve performance while maintaining patient safety. Responsibilities
Support 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) as a business process analyst, technical writer, project manager, computer systems validation specialist, and other delivery roles. Implement 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 also work on teams to deliver quality client services by applying technical capabilities and maintaining long-term client relationships. Travel required up to 40% for full-time employment. Qualifications
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 experience with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs, or integration of risk management functions. Ideal Skills
Experience implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. What We Look For
Passionate leaders with strong delivery capability and a desire to stay current with life sciences industry trends. Ability to help businesses drive measurable value while serving patients. What We Offer You
Comprehensive compensation and benefits package with base salary ranges (e.g., $93,600 to $154,500; NYC Metro etc.) and a Total Rewards program including medical and dental coverage, pension/401(k), and paid time off options. Hybrid work model with in-person collaboration approximately 40-60% of the time depending on engagements. Flexible vacation policy and designated holidays, personal/family care time, and other leaves of absence to support well-being. Are you ready to shape your future with confidence? Apply today. EY accepts applications on an ongoing basis. For California residents, additional information is available. EY focuses on high ethical standards and integrity and is committed to equal employment opportunities for 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 provides reasonable accommodations to qualified individuals with disabilities, including veterans with disabilities. If you need assistance applying online or require an accommodation during any part of the application process, please call 1-800-EY-HELP3 and follow the prompts to reach EY’s Talent Shared Services Team (TSS) or email ssc.customersupport@ey.com.
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Join to apply for the 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 and help clients in the Life Sciences sector improve performance while maintaining patient safety. Responsibilities
Support 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) as a business process analyst, technical writer, project manager, computer systems validation specialist, and other delivery roles. Implement 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 also work on teams to deliver quality client services by applying technical capabilities and maintaining long-term client relationships. Travel required up to 40% for full-time employment. Qualifications
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 experience with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs, or integration of risk management functions. Ideal Skills
Experience implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. What We Look For
Passionate leaders with strong delivery capability and a desire to stay current with life sciences industry trends. Ability to help businesses drive measurable value while serving patients. What We Offer You
Comprehensive compensation and benefits package with base salary ranges (e.g., $93,600 to $154,500; NYC Metro etc.) and a Total Rewards program including medical and dental coverage, pension/401(k), and paid time off options. Hybrid work model with in-person collaboration approximately 40-60% of the time depending on engagements. Flexible vacation policy and designated holidays, personal/family care time, and other leaves of absence to support well-being. Are you ready to shape your future with confidence? Apply today. EY accepts applications on an ongoing basis. For California residents, additional information is available. EY focuses on high ethical standards and integrity and is committed to equal employment opportunities for 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 provides reasonable accommodations to qualified individuals with disabilities, including veterans with disabilities. If you need assistance applying online or require an accommodation during any part of the application process, please call 1-800-EY-HELP3 and follow the prompts to reach EY’s Talent Shared Services Team (TSS) or email ssc.customersupport@ey.com.
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