Senior Quality & Supply Chain Operations

EY; Detroit (MI); À distance; USD 97 000 - 195 000; Plein temps

Résumé du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, implement, and validate digital quality solutions for regulated environments. You will connect QA/QC with laboratory and manufacturing data, while aligning with GxP and data integrity standards.

You will work across QA, QC, laboratory, regulatory, IT, and operations teams to deliver scalable, auditable quality processes, AI-enabled insights, and robust traceability.

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.
• At least 3 years of experience in Life Sciences quality, QA/QC, or related field.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience with core quality processes: deviations, investigations, CAPA, change control, complaints, audits, supplier quality, batch disposition, release, or quality risk management.
• Experience producing technical or functional delivery artifacts: requirements, process maps, data mappings, interface specifications, configuration documents, test scripts, validation evidence, deployment materials.

Responsabilités

• Assess quality and laboratory workflows, user needs, system interfaces, data, and pain points through interviews and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities spanning deviations, investigations, CAPA, change control, audits, supplier quality, batch release, and quality 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, and other lab data systems; support data integration and traceability.
• Develop and review data models, source-to-target mappings, data-quality rules, and contextualized datasets relating quality events to products and processes.
• Work with solution architects on interface specifications, APIs, laboratory-instrument connectivity, and secure data movement.
• 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, risks, and test evidence.
• Support deployment readiness, training, and handover by documenting processes and responding to issues from users.
• Partner with client QA/validation teams to address GxP/GMP, data integrity, electronic records, validated changes, audit trails, and end-to-end traceability.
• Integrate and contextualize data to identify trends, support root-cause analysis, and improve quality decision-making.
• Contribute to governed AI applications for quality with human-in-the-loop review and governance.

Connaissances

Quality-domain exp

Digital QMS

QA/QC integration

LIMS integration

Data modeling

Test script development

GxP knowledge

AI in quality

Technical communication

Formation

Bachelor’s degree in life sciences / related field

Description du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, implement, and validate digital quality solutions for regulated environments. You will connect QA/QC with laboratory and manufacturing data, while aligning with GxP and data integrity standards.

You will work across QA, QC, laboratory, regulatory, IT, and operations teams to deliver scalable, auditable quality processes, AI-enabled insights, and robust traceability.