EY
Digital QualityTransformation - Senior Consultant - Life Sciences (QMS)
EY, Dallas, Texas, United States, 75215
Overview
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’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting organization performance and patient safety. 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 maintaining growth, aligning risk and business objectives from strategy to execution. The opportunity involves working with life sciences clients to develop business processes and design and implement systems governed by the FDA and similar global regulatory bodies. Your Key Responsibilities
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 professional, 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. Work with teams to deliver high-quality client services and maintain long-term client relationships. Full-time employment; travel required up to 40%. 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. 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 strong passion for helping businesses drive measurable value while serving patients, then this role is for you. What We Offer You
Comprehensive compensation and benefits package. Base salary range varies by location; Total Rewards includes medical and dental coverage, pension/401(k), and paid time off options. Hybrid work model: most client-facing roles are expected to work in person 40-60% of the time during engagements. Flexible vacation policy with time off for holidays and 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 emphasizes equal employment opportunities and integrity among its employees. Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing and Sales Industries
Professional Services EY focuses on building a better working world by delivering value to clients, people, society and the planet, enabled by data, AI, and advanced technology. EY is committed to equal opportunity and providing accommodations on request.
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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. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting organization performance and patient safety. 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 maintaining growth, aligning risk and business objectives from strategy to execution. The opportunity involves working with life sciences clients to develop business processes and design and implement systems governed by the FDA and similar global regulatory bodies. Your Key Responsibilities
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 professional, 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. Work with teams to deliver high-quality client services and maintain long-term client relationships. Full-time employment; travel required up to 40%. 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. 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 strong passion for helping businesses drive measurable value while serving patients, then this role is for you. What We Offer You
Comprehensive compensation and benefits package. Base salary range varies by location; Total Rewards includes medical and dental coverage, pension/401(k), and paid time off options. Hybrid work model: most client-facing roles are expected to work in person 40-60% of the time during engagements. Flexible vacation policy with time off for holidays and 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 emphasizes equal employment opportunities and integrity among its employees. Seniority level
Mid-Senior level Employment type
Full-time Job function
Marketing and Sales Industries
Professional Services EY focuses on building a better working world by delivering value to clients, people, society and the planet, enabled by data, AI, and advanced technology. EY is committed to equal opportunity and providing accommodations on request.
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