Lead Digital Quality Transformation Consultant – Life Sciences

EY; Charlotte (NC); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Hybrid work model

Healthcare benefits

Pension and 401(k)

Paid time off

Flexible vacation policy

Job summary

EY in the United States is seeking a Life Sciences Risk Consulting professional to help clients identify, manage, and respond to risks while accelerating performance in regulatory compliance and quality systems.

You will work on QMS, LIMS, and validation projects across biopharma, medical devices, and biotech, with a hybrid work model and a comprehensive benefits package.

Strong collaboration and delivery experience required.

Qualifications

• Bachelor's or master's degree and at least three years of related Life Sciences work experience.
• Experience with Life Sciences regulatory statutes, GxP processes, risk management or compliance programs.
• Experience implementing Veeva Vaults, LIMS, or Validation Lifecycle Management Systems.
• Ability to work across teams to deliver high-quality client services.

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.
• Design and execution of QMS and Regulatory processes.
• Performing computer systems validation activities and quality audits of client processes.

Skills

Regulatory knowledge

Quality management

Project management

Cross-functional collaboration

Education

Bachelor's or Master's degree in Life Sciences, Engineering, or related field

Tools

Veeva Vaults

LIMS

ValGenesis

Kneat

Job description

EY in the United States is seeking a Life Sciences Risk Consulting professional to help clients identify, manage, and respond to risks while accelerating performance in regulatory compliance and quality systems.

You will work on QMS, LIMS, and validation projects across biopharma, medical devices, and biotech, with a hybrid work model and a comprehensive benefits package.

Strong collaboration and delivery experience required.