Senior Quality & Digital QMS Ops (Life Sciences)

EY; Portland (OR); Remote; USD 97,000 - 178,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) plan

Paid time off options

Job summary

EY is hiring a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital quality solutions for regulated environments. You will connect QA/QC, laboratory, manufacturing, and IT teams across lifecycle stages, from assessments through validation, deployment, and stabilization.

You will collaborate with QA, QC, laboratory, regulatory, IT, and data teams to deliver compliant designs, data mappings, and test evidence, while ensuring traceability and quality controls

Responsibilities

• 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, supplier quality, batch disposition and release, review by exception, and quality risk management.
• Design and improve digital‑quality workflows using eQMS/QMS platforms, including workflow configuration, records management, approvals, escalation paths, effectiveness checks, reporting, and integration with adjacent enterprise systems.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other laboratory data systems, and relevant manufacturing platforms; support assays, stability programs, OOS/OOT traceability, deviation and CAPA analysis, and batch‑review workflows.
• Develop and review quality and laboratory data models, source‑to‑target mappings, data‑quality rules, and contextualized datasets that relate quality events to products, materials, batches, methods, specifications, instruments, equipment, and process conditions.
• Work with solution architects and engineers on interface specifications, APIs, laboratory‑instrument connectivity, and the secure movement of quality, laboratory, manufacturing, equipment, and process data across site and enterprise environments.
• Configure or prototype solution components where appropriate to your experience and the engagement, and document design decisions for review by quality, technical, and client leads.
• Prepare and execute functional and integration test scripts, record defects, support resolution and retesting, and maintain traceability between requirements, risks, controls, and test evidence.
• Support deployment readiness, controlled change, user training, hyper‑care, and handover by preparing clear documentation and responding to issues from quality and laboratory users.
• Partner with client quality and validation teams to prepare or review documentation addressing GxP/GMP, data integrity, electronic records and signatures, controlled change, validation or risk‑based assurance, audit trails, and end‑to‑end traceability.
• Integrate and contextualize quality, laboratory, manufacturing, equipment, and process data to identify recurring events, detect trends, support root‑cause analysis, and improve quality decision‑making.
• Contribute to governed AI applications for Quality, including AI‑assisted investigations and root‑cause analysis, anomaly and trend detection, predictive quality, and decision support, with appropriate human‑in‑the‑loop review, governance, and controls.
• Communicate progress, risks, dependencies, and recommended next steps to client counterparts and engagement leaders; coordinate defined tasks with junior colleagues when needed.

Job description

EY is hiring a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital quality solutions for regulated environments. You will connect QA/QC, laboratory, manufacturing, and IT teams across lifecycle stages, from assessments through validation, deployment, and stabilization.

You will collaborate with QA, QC, laboratory, regulatory, IT, and data teams to deliver compliant designs, data mappings, and test evidence, while ensuring traceability and quality controls