Senior Quality & Supply Chain (Digital QMS)

EY; Columbus (OH); À distance; USD 97 000 - 203 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage

Pension and 401(k)

Paid time off

Résumé du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help connect QA/QC, laboratory, and manufacturing data with deployable technology across GMP environments.

You will craft requirements, design workflows, and guide validation and deployment while collaborating with cross-functional teams. Travel up to 100% may be required; strong regulatory and data-analytics skills are essential.

Qualifications

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

Responsabilités

• Assess quality and lab workflows, user needs, data interfaces, and pain points through workshops and data review.
• Document process flows, user stories, functional requirements, data mappings, and quality-system controls.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, audits, and release.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with enterprise systems.
• Contextualize QA/QC data across LIMS, eQMS/QMS, MES, ERP, and lab data systems.
• Develop data models, source-to-target mappings, and data-quality rules.
• Collaborate with architects on interfaces, APIs, and data movement across environments.
• Prepare functional/integration test scripts and maintain traceability to requirements and risks.
• Support deployment readiness, user training, and handover with thorough documentation.
• Engage client quality/validation teams addressing GxP, data integrity, electronic records, and end-to-end traceability.
• Contribute to AI-enabled quality applications with governance and human-in-the-loop review.

Connaissances

Quality-domain expertise

Digital QMS

QA/QC integration

Data integration

GxP knowledge

Analytical judgment

Technical communication

AI in Quality

Formation

Bachelor's degree in life sciences

Outils

LIMS

eQMS/QMS platforms

APIs

Description du poste

EY is seeking a Senior in Supply Chain Manufacturing Quality to help connect QA/QC, laboratory, and manufacturing data with deployable technology across GMP environments.

You will craft requirements, design workflows, and guide validation and deployment while collaborating with cross-functional teams. Travel up to 100% may be required; strong regulatory and data-analytics skills are essential.