Digital Quality Transformation Consultant - Life Sciences

EY; McLean (VA); 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 Life Sciences Risk Consulting Services is seeking professionals to help clients in biotechnology, pharmaceuticals, medical devices, and related industries identify, manage, and respond to regulatory and quality risks. You will design and implement systems for FDA/GxP governed processes, including QMS, LIMS, and regulatory submissions.

Travel up to 40% is required; the team supports quality audits, regulatory affairs, and validation lifecycle management across manufacturing, R&D, and supply

Qualifications

• A bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field and at least three years of related work experience.

Responsibilities

• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in roles such as business process analyst, technical writer, project manager, and CSV.

Skills

Quality Management

Regulatory Affairs

LIMS

CSV (Computer Systems Validation)

Education

Bachelor's/Master in CS or Life Sciences

Tools

Veeva Vaults

LIMS

ValGenesis

Kneat

Trackwise

EtQ Reliance

Argus

Calyx

Job description

EY Life Sciences Risk Consulting Services is seeking professionals to help clients in biotechnology, pharmaceuticals, medical devices, and related industries identify, manage, and respond to regulatory and quality risks. You will design and implement systems for FDA/GxP governed processes, including QMS, LIMS, and regulatory submissions.

Travel up to 40% is required; the team supports quality audits, regulatory affairs, and validation lifecycle management across manufacturing, R&D, and supply