Senior Quality & Digital QMS Lead – Supply Chain

EY; Des Moines (IA); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension and 401(k)

Paid time off

Zusammenfassung

EY seeks a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology across regulated environments.

You will lead quality-dominant design, testing, validation, and deployment activities, guiding teams through complex data and systems while ensuring compliance with GxP/GMP and data integrity requirements. EY offers global opportunity and strong rewards.

Qualifikationen

• 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 lab systems experience.
• Experience with QA/QC and manufacturing processes in regulated environments.
• Experience delivering requirements, process maps, data mappings, interface specs, or validation materials.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, data points, and pain points.
• Document process flows, user stories, functional requirements, data mappings, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, investigations, and inspections readiness.
• Design and improve digital-quality workflows using eQMS/QMS platforms with records management, approvals, and integration.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP and related systems; support data traceability.
• Develop and review data models, source-to-target mappings, data-quality rules, and contextualized datasets.
• Collaborate with solution architects on interface specs, APIs, and data movement across environments.
• Configure or prototype solution components and document design decisions for review.
• Prepare and execute functional and integration test scripts; maintain traceability between requirements, risks, controls, and tests.
• Support deployment readiness, training, and handover with clear documentation.
• Partner with client teams on GxP/GMP documentation, data integrity, electronic records, and end-to-end traceability.
• Integrate data to identify trends, support root-cause analysis, and improve quality decisions.
• Contribute to governed AI applications for Quality with human-in-the-loop governance.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC integration

Quality data mapping

Delivery discipline

Technical communication

GxP controls

Analytics/AI in QA

Ausbildung

Bachelor’s degree in life sciences or related

Tools

LIMS

eQMS/QMS platforms

Jobbeschreibung

EY seeks a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology across regulated environments.

You will lead quality-dominant design, testing, validation, and deployment activities, guiding teams through complex data and systems while ensuring compliance with GxP/GMP and data integrity requirements. EY offers global opportunity and strong rewards.