Life Sciences Quality Transformation Consultant

EY; Pittsburgh (Allegheny County); Hybrid; USD 94,000 - 175,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Hybrid work model

Job summary

EY Life Sciences Risk Consulting Services seeks professionals to help clients in biotech, pharma, medical devices, and related sectors address regulatory and quality challenges. You will implement QMS, LIMS, and validation systems, supporting risk-based decision making and ensuring compliance with FDA and global regulations.

The role involves delivering end-to-end project work with travel up to 40%, contributing to risk assessment, regulatory submissions, and system validations for life sciences

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or related field.
• At least three years of related work experience in Life Sciences.
• Experience with Life Science regulatory statutes, GxP processes or system validations.

Responsibilities

• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) as business process analyst, technical writer, project manager, computer systems validation, or related delivery 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

Regulatory experience

GxP knowledge

Project delivery

Education

Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or related field

Tools

Veeva Vaults

LIMS

Validation lifecycle management

Job description

EY Life Sciences Risk Consulting Services seeks professionals to help clients in biotech, pharma, medical devices, and related sectors address regulatory and quality challenges. You will implement QMS, LIMS, and validation systems, supporting risk-based decision making and ensuring compliance with FDA and global regulations.

The role involves delivering end-to-end project work with travel up to 40%, contributing to risk assessment, regulatory submissions, and system validations for life sciences