Senior Quality & Digital QMS Lead – Supply Chain

EY; Jacksonville (FL); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

401(k) plan

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing with deployable digital solutions. You will work across quality systems, data integration, and AI-enabled quality workflows.

You will design, configure, test, validate, and deploy digital quality capabilities, collaborating with QA/QC teams to ensure GxP/GMP compliance and end-to-end traceability across systems.

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.
• 3+ years of experience in Life Sciences quality, QA/QC, or related areas.
• Experience with quality, laboratory, or manufacturing processes in regulated environments (pharma/biotech/medical devices).
• Experience with core quality processes (deviations, investigations, CAPA, change control, audits, supplier quality, batch disposition, release, risk management).
• Experience producing technical delivery artifacts (requirements, process maps, data mappings, interface specs, validation evidence, deployment materials).
• Willingness to travel 80-100% as needed.
• Authorized to work in the U.S. without sponsorship now or in the future.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, and data, identifying pain points and opportunities.
• Document process flows, user stories, requirements, data mappings, and acceptance criteria for digital quality solutions.
• Design and implement quality-domain capabilities across deviations, CAPA, change control, audits, and inspections.
• Configure and improve digital-quality workflows using eQMS/QMS platforms and integrations.
• Connect QA/QC and lab processes across LIMS, MES, ERP, and related systems; support data integrity and traceability.
• Develop data models, source-to-target mappings, and data-quality rules for quality events.
• Collaborate with architects on interfaces, APIs, and secure data movement.
• Prepare and execute functional and integration tests; maintain traceability from requirements to tests.

Kenntnisse

Quality-domain

Digital QMS

QA/QC integration

Quality data

Delivery discipline

Technical communication

GxP controls

Analytical judgment

Ausbildung

Bachelor's degree

Tools

LIMS

eQMS/QMS

APIs

Data integration

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing with deployable digital solutions. You will work across quality systems, data integration, and AI-enabled quality workflows.

You will design, configure, test, validate, and deploy digital quality capabilities, collaborating with QA/QC teams to ensure GxP/GMP compliance and end-to-end traceability across systems.