Hybrid Life Sciences Quality Transformation Consultant

EY; Boston (MA); Hybrid; USD 94,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

Pension

401(k)

Paid time off

Hybrid work model

Flexible vacation policy

Job summary

EY in the United States is seeking a Life Sciences Risk Consulting professional to help pharmaceutical, biotech, and medical device clients identify, manage, and respond to regulatory and operational risks while accelerating performance in a heavily regulated environment.

You will implement QMS, DMS, LIMS, and regulatory processes, perform computer systems validation, support quality audits, and help design and operate compliant systems across FDA and global regulatory bodies.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or related field with 3+ years in Life Sciences.
• Experience with Life Science regulatory statutes, GxP, risk management or compliance programs.

Responsibilities

• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx).
• Design and execute Regulatory processes and validation activities.
• Perform quality audits and work to deliver high-quality client services with long-term relationships.

Skills

Life Sciences experience

Risk management

Regulatory awareness

Education

Bachelor’s or Master’s in Computer Science or related field

Tools

Veeva Vaults

LIMS

Validation Lifecycle Management

Job description

EY in the United States is seeking a Life Sciences Risk Consulting professional to help pharmaceutical, biotech, and medical device clients identify, manage, and respond to regulatory and operational risks while accelerating performance in a heavily regulated environment.

You will implement QMS, DMS, LIMS, and regulatory processes, perform computer systems validation, support quality audits, and help design and operate compliant systems across FDA and global regulatory bodies.