Senior Life Sciences Quality & Digital QMS Lead

EY; West Virginia; Remote; USD 97,000 - 203,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, build, test, and deploy digital quality solutions for regulated environments in pharmaceutical, biotech, and medical-device sectors. You’ll connect QA/QC, laboratory, and manufacturing needs with deployable technology across the delivery lifecycle.

You will collaborate with QA, QC, IT, data, and validation teams, own key deliverables, and translate workflows into compliant designs and testable requirements.

Qualifications

• Bachelor’s degree in life sciences or related field.
• At least 3 years in Life Sciences quality or related.
• Experience with pharmaceutical/regulated environments.
• Experience delivering artifacts like requirements, process maps, data mappings, or test materials.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, data flows, and pain points.
• Document process flows, user stories, and functional requirements for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, and audits.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with enterprise systems.
• Connect QA/QC and laboratory processes across LIMS, MES, ERP, and related data systems.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Data modeling

AI governance

Education

Bachelor’s degree in life sciences

Tools

LIMS

eQMS/QMS

APIs

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, build, test, and deploy digital quality solutions for regulated environments in pharmaceutical, biotech, and medical-device sectors. You’ll connect QA/QC, laboratory, and manufacturing needs with deployable technology across the delivery lifecycle.

You will collaborate with QA, QC, IT, data, and validation teams, own key deliverables, and translate workflows into compliant designs and testable requirements.