Senior Digital Quality & Supply Chain Leader

EY; Rogers (AR); Remote; USD 97.000 - 203.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension plan

401(k) plans

Paid time off

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology. You will guide quality lifecycle activities from assessments through validation and deployment, working with cross‑functional teams across regulated environments.

You will lead design, testing, and implementation of digital quality workflows, data integration, and AI-enabled quality capabilities, while ensuring data integrity and compliant traceability in

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, or a related discipline.
• At least 3 years of relevant experience in Life Sciences quality, QA/QC, or digital QMS.
• Experience with regulated environments (GxP/GMP) and data integrity.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and data points through interviews, workshops, process observation, and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, quality-system controls, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities spanning deviations, nonconformances, investigations, CAPA, change control, complaints, audits, supplier quality, batch disposition and release, and risk management.
• Design and improve digital-quality workflows using eQMS/QMS platforms, including workflow configuration, records management, approvals, escalation paths, and reporting.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other laboratory data systems, and relevant manufacturing platforms.
• Develop and review quality and laboratory data models, source-to-target mappings, data-quality rules, and contextualized datasets that relate quality events to products and processes.
• Work with solution architects and engineers on interface specifications, APIs, and data movement across environments.
• Configure or prototype solution components and document design decisions for review by quality, technical, and client leads.
• Prepare and execute functional and integration test scripts, record defects, and maintain traceability between requirements and test evidence.
• Support deployment readiness, training, and handover with clear documentation.
• Partner with client quality and validation teams on GxP, data integrity, and audit trails documentation.
• Integrate data to identify recurring events, trends, and improve quality decision-making.
• Contribute to governed AI applications for Quality with governance and controls.
• Communicate progress, risks, and next steps to client counterparts and engagement leaders.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC and laboratory integration

Quality data and integration

Delivery discipline

Technical communication

GxP and quality-system controls

Analytical judgment

Ausbildung

Bachelor’s degree in Life Sciences/Quality/Engineering/IS

Tools

eQMS/QMS platforms

LIMS integration

Data systems interfaces

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology. You will guide quality lifecycle activities from assessments through validation and deployment, working with cross‑functional teams across regulated environments.

You will lead design, testing, and implementation of digital quality workflows, data integration, and AI-enabled quality capabilities, while ensuring data integrity and compliant traceability in