Senior Quality & Digital QMS Lead – Life Sciences

EY; Louisville (KY); Teletrabalho; USD 97 000 - 195 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical and dental coverage

Pension/401(k) plans

Generous paid time off

Resumo da oferta

EY is seeking a Senior in Supply Chain Manufacturing Quality to work with pharmaceutical, biotech, and medical‑device clients across regulated QA/QC and digital QMS domains. You will connect QA/QC, laboratory, manufacturing, and IT teams, owning deliverables from requirements to deployment and ensuring traceability and data integrity.

You will design and implement digital‑quality workflows, support AI‑enabled quality applications, and collaborate across disciplines to drive compliant, end‑to‑end

Qualificações

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevant Life Sciences quality, QA/QC, or laboratory systems experience.
• Experience with quality processes such as deviations, CAPA, change control, audits, and data integrity.
• Experience producing technical or functional delivery artifacts (requirements, test scripts, validation evidence).
• Ability to travel 80–100% as required by business needs.
• Authorized to work in the U.S. without employer sponsorship.

Responsabilidades

• Assess quality and laboratory workflows, user needs, data interfaces, and pain points.
• Document requirements, data mappings, interface specs, and QA‑system controls.
• Support deviations, CAPA, change control, and batch release workflows.
• Configure digital‑quality workflows and integrate with LIMS, eQMS, MES, and ERP systems.
• Prepare functional and integration test scripts and maintain traceability.
• Support deployment readiness, user training, and handover activities.
• Collaborate with QA, validation, and IT teams on governance and data integrity.

Conhecimentos

GxP/quality controls

Technical communication

Analytical judgment

Delivery discipline

Data integration

Travel readiness

Regulatory experience

Formação académica

Bachelor’s degree in life sciences or related

Ferramentas

LIMS

eQMS/QMS platforms

Descrição da oferta de emprego

EY is seeking a Senior in Supply Chain Manufacturing Quality to work with pharmaceutical, biotech, and medical‑device clients across regulated QA/QC and digital QMS domains. You will connect QA/QC, laboratory, manufacturing, and IT teams, owning deliverables from requirements to deployment and ensuring traceability and data integrity.

You will design and implement digital‑quality workflows, support AI‑enabled quality applications, and collaborate across disciplines to drive compliant, end‑to‑end