Digital Quality Transformation Lead Life Sciences

EY; Hoboken (NJ); Hybrid; USD 94,000 - 155,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY’s Life Sciences Risk Consulting Services team helps biotechnology, pharma, medical device and related industries identify, manage and respond to risks while accelerating performance and growth.

Your role focuses on implementing Quality Management and Regulatory processes, managing risk, and delivering high-quality client services across life sciences engagements. This is a full-time, hybrid role requiring up to 40% travel and a degree plus 3+ years in Life Sciences.

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 working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions.
• Ideally, experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

Responsibilities

• Support client engagement teams to deliver projects in the life sciences domain.
• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in various 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.

Skills

Life Sciences

GxP Compliance

Regulatory Affairs

Project management

Veeva Vaults

LIMS

Education

Bachelor’s or Master’s in CS / Biomed Eng / QE / Manufacturing

Tools

LIMS

ValGenesis / Kneat

Job description

EY’s Life Sciences Risk Consulting Services team helps biotechnology, pharma, medical device and related industries identify, manage and respond to risks while accelerating performance and growth.

Your role focuses on implementing Quality Management and Regulatory processes, managing risk, and delivering high-quality client services across life sciences engagements. This is a full-time, hybrid role requiring up to 40% travel and a degree plus 3+ years in Life Sciences.