Senior Quality & Digital QMS Specialist Life Sciences

EY; Los Angeles (CA); Remote; USD 137,000 - 162,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology. You will influence quality processes from assessments through design, configuration, testing, validation, deployment, and adoption across pharmaceutical, biotech, and medical-device clients.

You will own technical deliverables, resolve issues, and translate workflows into compliant designs with human-in-the-loop governance.

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevant Life Sciences quality, QA, QC, or digital QMS experience.
• Experience with pharmaceutical/biotech/medical-device regulated environments.
• Experience producing technical or functional delivery artifacts such as requirements, maps, data mappings, interfaces, or validation evidence.
• Ability to travel 80-100% as needed.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, and data pain points.
• Document process flows, user stories, requirements, data mappings, and interface specs.
• Support design and implementation of digital quality capabilities across deviations, CAPA, change control, complaints, audits, and inspection readiness.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integrate with ERP/LIMS.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, and lab data systems.
• Develop and review data models, mappings, data-quality rules, and contextual datasets linking quality events to products and processes.
• Collaborate with architects on API specs, instrument connectivity, and secure data movement.
• Prepare and execute functional/integration tests, log defects, and ensure traceability to requirements and risks.
• Support deployment readiness, training, and handover with clear documentation.
• Partner with client teams on GxP data integrity, electronic records, controlled change, and audit trails.
• Contribute to governed AI applications for quality, including AI-assisted investigations and trend detection.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Data modeling

Delivery discipline

Technical communication

GxP knowledge

Analytical judgment

Education

Bachelor’s degree in life sciences, quality, engineering, information systems, or related

Tools

LIMS

eQMS/QMS platforms

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology. You will influence quality processes from assessments through design, configuration, testing, validation, deployment, and adoption across pharmaceutical, biotech, and medical-device clients.

You will own technical deliverables, resolve issues, and translate workflows into compliant designs with human-in-the-loop governance.