Senior Consultant, Digital Quality Transformation

EY; New York (NY); Hybrid; USD 94,000 - 155,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Hybrid work model

Job summary

EY’s Life Sciences Risk Consulting Services invites professionals to join a team focused 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.

The role covers regulatory compliance, quality management systems, and validation lifecycle activities, with up to 40% travel and a hybrid work model in the US.

Qualifications

• Bachelor's or master's degree in a relevant 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 processes or system validations.
• Experience with 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).
• 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.

Skills

Risk management

Quality systems

Regulatory knowledge

Project management

GxP awareness

Education

BSc/MSc in CS or related

Tools

Veeva Vaults

LIMS

ValGenesis

Kneat

Job description

EY’s Life Sciences Risk Consulting Services invites professionals to join a team focused 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.

The role covers regulatory compliance, quality management systems, and validation lifecycle activities, with up to 40% travel and a hybrid work model in the US.