Senior Quality & Digital QMS Lead – Life Sciences

EY; Toledo (OH); Remote; USD 97,000 - 195,000; 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 connect QA/QC, laboratory, and manufacturing needs with deployable technology in regulated environments. You will contribute across the delivery lifecycle from assessments to validation, deployment, and stabilization.

You will work with QA/QC, IT, data, and technology teams, own deliverables, and translate workflows into compliant designs and testable requirements for audit-ready solutions.

Qualifications

• Bachelor's degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.
• Experience in Life Sciences quality, QA/QC, or digital quality systems is preferred.
• Experience working with regulated environments (pharma, biotech, medical devices).
• Ability to travel as needed up to 80-100% depending on project requirements.

Responsibilities

• Assess quality and laboratory workflows, user needs, interfaces, data, and pain points through interviews and data review.
• Document process flows, requirements, data mappings, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, audits, and batch release.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with ERP/LIMS.
• Integrate QA/QC and lab data across LIMS, eQMS/QMS, MES, ERP, and related systems.

Skills

Quality domain

Digital QMS

QA/QC integration

Data integration

Delivery discipline

Technical communication

GxP compliance

AI in Quality

Education

Bachelor's degree

Tools

LIMS

eQMS/QMS platforms

Data systems

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to help connect QA/QC, laboratory, and manufacturing needs with deployable technology in regulated environments. You will contribute across the delivery lifecycle from assessments to validation, deployment, and stabilization.

You will work with QA/QC, IT, data, and technology teams, own deliverables, and translate workflows into compliant designs and testable requirements for audit-ready solutions.