Life Sciences Quality Transformation Consultant

EY; Philadelphia (Philadelphia County); Hybrid; USD 94,000 - 176,000; Full time

Benefits offered by this job

Hybrid work model

Travel up to 40%

Comprehensive benefits

Job summary

EY is seeking a Life Sciences Risk Consultant to help clients identify, manage, and respond to regulatory and quality risks across QMS, LIMS, and CV systems. You will contribute to project delivery from strategy to execution within a global, diverse team.

The role requires a bachelor’s or master’s degree and at least three years in Life Sciences, with experience in regulatory compliance and risk management. A hybrid work model and extensive client exposure are offered.

Qualifications

• Bachelor's or Master's degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field with at least three years of related work experience.
• 3+ years of Life Sciences work experience, including regulatory statutes, GxP processes, risk management or compliance programs.

Responsibilities

• Support client engagement teams to deliver projects in life sciences, including implementing QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx).
• Design and execution of QMS and Regulatory processes; perform computer systems validation activities.
• Lead audits of client processes within the QMS area; manage risks and ensure stakeholder communication.
• Travel required up to 40%.

Skills

Life Sciences expertise

Risk management

Project management

Regulatory compliance

Stakeholder management

Education

Bachelor's or Master's in a related field

Tools

Veeva Vaults

LIMS

Validation Lifecycle Management Systems

Job description

EY is seeking a Life Sciences Risk Consultant to help clients identify, manage, and respond to regulatory and quality risks across QMS, LIMS, and CV systems. You will contribute to project delivery from strategy to execution within a global, diverse team.

The role requires a bachelor’s or master’s degree and at least three years in Life Sciences, with experience in regulatory compliance and risk management. A hybrid work model and extensive client exposure are offered.