Life Sciences Quality Transformation Consultant

EY; Dallas (TX); Hybrid; USD 94,000 - 155,000; Full time

Benefits offered by this job

Hybrid work model

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY’s Life Sciences Risk Consulting Services helps biotech, pharma and medical device clients align risk and business objectives, designing systems to manage FDA-regulated processes and drive performance.

You’ll support client teams delivering QMS, LIMS and regulatory solutions, applying validation and risk management to ensure compliant, scalable outcomes across global life sciences programs.

Qualifications

• Bachelor’s or master’s degree and 3+ years in life sciences.
• Experience with Life Science regulatory statutes, GxP processes or system validations.
• Experience implementing Veeva Vaults, LIMS, or Validation Lifecycle Management Systems.

Responsibilities

• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in delivery roles.
• Design and execution of QMS and Regulatory processes.
• Perform computer systems validation activities as part of a service.
• Conduct quality audits of client processes within the QMS area.
• Travel up to 40% and support client engagements in Life Sciences.

Skills

Project management

Risk management

Quality/regulatory knowledge

Stakeholder communication

Education

Bachelor's or Master's in Computer Science / Biomedical Engineering / Quality Engineering / Manufacturing or related field

Tools

Veeva Vaults

LIMS

ValGenesis

Kneat

Trackwise

EtQ Reliance

Argus

Calyx

Job description

EY’s Life Sciences Risk Consulting Services helps biotech, pharma and medical device clients align risk and business objectives, designing systems to manage FDA-regulated processes and drive performance.

You’ll support client teams delivering QMS, LIMS and regulatory solutions, applying validation and risk management to ensure compliant, scalable outcomes across global life sciences programs.