Senior Life Sciences Quality & Digital QMS Lead

EY; San Diego (CA); Remote; USD 97,000 - 178,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) plan

Paid time off

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality. You will connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions across regulated environments.

The role covers design, configuration, testing, validation, deployment, and stabilization of QMS workflows and data integration, working with cross-functional teams. You will own deliverables, resolve issues, and translate lab workflows into compliant designs and testable requirements.

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, or related discipline.
• At least 3 years in Life Sciences quality, QA/QC, or digital QMS environments.
• Experience with quality, laboratory, or manufacturing processes in regulated settings.
• Experience delivering technical artifacts: requirements, data mappings, interfaces, or validation materials.

Responsibilities

• Assess quality and lab workflows, user needs, system data, and pain points through interviews and data review.
• Document process flows, user stories, data mappings, interface requirements, and acceptance criteria for digital quality solutions.
• Design and improve digital quality workflows across eQMS/QMS, records management, and integration with ERP/LIMS systems.
• Prepare and execute functional and integration test scripts; maintain traceability between requirements, risks, controls, and tests.
• Support deployment readiness, training, and handover with client teams; ensure QA/QC and data integrity across systems.

Skills

Quality-domain

Digital QMS

QA/QC integration

Data integration

Delivery discipline

Technical comms

GxP controls

AI in quality

Education

Bachelor's degree

Tools

LIMS

eQMS

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality. You will connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions across regulated environments.

The role covers design, configuration, testing, validation, deployment, and stabilization of QMS workflows and data integration, working with cross-functional teams. You will own deliverables, resolve issues, and translate lab workflows into compliant designs and testable requirements.