Senior Life Sciences Quality Transformation Consultant

EY; Detroit (MI); Hybrid; USD 94,000 - 176,000; Full time

Job summary

EY’s Life Sciences Risk Consulting Services helps manufacturers of biotec, pharma, medical devices and related sectors manage risk while driving performance. You will implement QMS, LIMS and validation lifecycle systems, perform audits, and work on regulatory compliance projects for FDA-regulated environments.

The role supports client teams, requires 3+ years in Life Sciences and a degree in CS/engineering, and offers a hybrid work model with up to 40% travel.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field; 3+ 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.

Responsibilities

• Support client engagement teams to deliver projects in life sciences: 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 and quality audits.

Skills

Life Sciences knowledge

GxP

Regulatory affairs

Risk management

Validation

Education

Computer Science

Biomedical Engineering

Quality Engineering

Manufacturing

Related field

Job description

EY’s Life Sciences Risk Consulting Services helps manufacturers of biotec, pharma, medical devices and related sectors manage risk while driving performance. You will implement QMS, LIMS and validation lifecycle systems, perform audits, and work on regulatory compliance projects for FDA-regulated environments.

The role supports client teams, requires 3+ years in Life Sciences and a degree in CS/engineering, and offers a hybrid work model with up to 40% travel.