Senior Digital Quality & Supply Chain Lead

EY; McLean (VA); À distance; USD 97 000 - 195 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

401(k) plan

Paid time off

Résumé du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help connect QA, QC, laboratory, manufacturing, and supply chain needs with deployable digital solutions. You will design, test, validate, and deploy digital quality workflows across LIMS, QMS, MES, and ERP systems for regulated environments.

You will work with cross-functional teams to translate complex quality processes into compliant design, tests, and deployment plans, with emphasis on GxP, data integrity, and AI-enabled quality

Qualifications

• Knowledge of deviations, investigations, CAPA, change control, complaints, audits, inspection readiness, supplier quality, batch disposition and release.
• Understanding of GxP and quality-system controls and data integrity requirements.
• Experience producing technical delivery artifacts such as requirements, process maps, data mappings, interface specifications, configuration documents, or test evidence.

Responsabilités

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and equipment data, and current-state pain 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 the design and implementation of quality-domain capabilities spanning deviations and nonconformances, investigations, CAPA, change control, complaints, audits, and inspection readiness.
• 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 data systems; support assays, stability programs, OOS/OOT traceability, and batch-review workflows.
• Develop and review quality and laboratory data models, source-to-target mappings, data-quality rules, and contextualized datasets.

Connaissances

Quality-domain expertise

Digital QMS

QA/QC integration

Data integration

GxP knowledge

Formation

Bachelor's degree in life sciences or related

Description du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help connect QA, QC, laboratory, manufacturing, and supply chain needs with deployable digital solutions. You will design, test, validate, and deploy digital quality workflows across LIMS, QMS, MES, and ERP systems for regulated environments.

You will work with cross-functional teams to translate complex quality processes into compliant design, tests, and deployment plans, with emphasis on GxP, data integrity, and AI-enabled quality