Senior Quality & Digital QMS Lead – Life Sciences

EY; City of Rochester (NY); A distancia; USD 97.000 - 178.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage

Pension and 401(k)

Paid time off options

Descripción de la vacante

EY seeks a Senior in Supply Chain Manufacturing Quality to help clients in pharmaceuticals, biotech, and medical devices connect QA/QC, lab, and manufacturing with deployable technology. You will own technical deliverables through the full delivery lifecycle, from requirements through validation and deployment.

You’ll collaborate with QA, QC, laboratory, IT, and business teams, shaping compliant, traceable digital quality workflows using eQMS/QMS platforms, LIMS, and related systems.

Formación

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, or related discipline.
• At least 3 years of Life Sciences quality, QA/QC, or digital QMS experience.
• Experience in regulated pharma/biotech/medical-device environments.
• Experience delivering requirements, data mappings, or validation artifacts.
• Willingness to travel as needed for engagements in the US.

Responsabilidades

• Assess quality and lab workflows, user needs, data interfaces, and pain points.
• Document process flows, requirements, data mappings, and quality controls.
• Support CAPA, deviations, change control, audits, and inspection readiness.
• Design digital-quality workflows using eQMS/QMS platforms and system integrations.
• Connect QA/QC and lab processes across LIMS, MES, ERP and related systems.
• Develop data models, mapping rules, and data quality controls.
• Collaborate on API specs, instrument connectivity, and secure data movement.
• Prototype components and document design decisions for review.
• Prepare functional and integration test scripts and maintain traceability.

Conocimientos

Quality-domain

Digital QMS

QA/QC integration

Quality data

Delivery discipline

Technical communication

GxP controls

Analytics judgement

Educación

Bachelor’s degree in Life Sciences or related field

Herramientas

LIMS

eQMS/QMS platforms

Descripción del empleo

EY seeks a Senior in Supply Chain Manufacturing Quality to help clients in pharmaceuticals, biotech, and medical devices connect QA/QC, lab, and manufacturing with deployable technology. You will own technical deliverables through the full delivery lifecycle, from requirements through validation and deployment.

You’ll collaborate with QA, QC, laboratory, IT, and business teams, shaping compliant, traceable digital quality workflows using eQMS/QMS platforms, LIMS, and related systems.