EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, Baltimore, Maryland, United States, 21276
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. EY focuses on helping clients in the Life Sciences sector manage risk and improve performance while ensuring patient safety. Responsibilities
Support client engagement teams to deliver projects in the Life Sciences domain, including implementation of Quality Management Systems (QMS), Documentation Management Systems (DMS), Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx). Participate in roles such as business process analyst, technical writer, project manager, and computer systems validation, delivering and executing project work. Implement validation lifecycle management systems (e.g. ValGenesis, Kneat). Design and execute QMS and Regulatory processes; perform computer systems validation activities as part of a service. Conduct quality audits of client processes within the QMS area. Collaborate on teams to consistently deliver high-quality client services and maintain long-term client relationships. Travel up to 40% as required. 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 experience. 3+ years of Life Sciences work experience, including exposure to 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 implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. What We Look For
Strong delivery capability and leadership with a passion for staying current with Life Sciences industry trends. Ability to drive measurable value for clients while serving patients. What We Offer You
Comprehensive compensation and benefits package, with base salary ranges depending on geography; plus medical and dental coverage, pension and 401(k), and Paid Time Off options. Hybrid work model; most client-facing roles require in-person collaboration 40-60% of the time over engagements. Flexible vacation policy and designated leave options for holidays and personal needs. EEO
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 reasonable accommodations for qualified individuals with disabilities, including veterans with disabilities. If you need assistance applying online or an accommodation during any part of the application process, please contact EY’s Talent Shared Services Team.
#J-18808-Ljbffr
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. EY focuses on helping clients in the Life Sciences sector manage risk and improve performance while ensuring patient safety. Responsibilities
Support client engagement teams to deliver projects in the Life Sciences domain, including implementation of Quality Management Systems (QMS), Documentation Management Systems (DMS), Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx). Participate in roles such as business process analyst, technical writer, project manager, and computer systems validation, delivering and executing project work. Implement validation lifecycle management systems (e.g. ValGenesis, Kneat). Design and execute QMS and Regulatory processes; perform computer systems validation activities as part of a service. Conduct quality audits of client processes within the QMS area. Collaborate on teams to consistently deliver high-quality client services and maintain long-term client relationships. Travel up to 40% as required. 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 experience. 3+ years of Life Sciences work experience, including exposure to 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 implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems. What We Look For
Strong delivery capability and leadership with a passion for staying current with Life Sciences industry trends. Ability to drive measurable value for clients while serving patients. What We Offer You
Comprehensive compensation and benefits package, with base salary ranges depending on geography; plus medical and dental coverage, pension and 401(k), and Paid Time Off options. Hybrid work model; most client-facing roles require in-person collaboration 40-60% of the time over engagements. Flexible vacation policy and designated leave options for holidays and personal needs. EEO
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 reasonable accommodations for qualified individuals with disabilities, including veterans with disabilities. If you need assistance applying online or an accommodation during any part of the application process, please contact EY’s Talent Shared Services Team.
#J-18808-Ljbffr