Senior Quality & Supply Chain Leader - Life Sciences

EY; Fort Worth (TX); Remote; USD 97.000 - 178.000; Vollzeit

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions for regulated environments.

You will work across QA, QC, laboratory, regulatory, IT, data, and technology teams, owning technical deliverables and guiding design, configuration, testing, validation, deployment, and adoption of quality workflows. Travel may be required, and a strong foundation in GxP controls is essential.

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, or related discipline.
• At least 3 years of relevant experience in Life Sciences quality, QA/QC, or related fields.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience producing technical delivery artifacts such as requirements, process maps, data mappings, interface specifications, or validation evidence.

Aufgaben

• Assess quality and laboratory workflows, interfaces, instrument and data data pain points.
• Document process flows, user stories, functional requirements, data mappings, and interface requirements.
• Support the design and implementation of quality-domain capabilities spanning deviations, investigations, CAPA, change control, audits, and inspection readiness.
• Design digital-quality workflows using eQMS/QMS platforms, including workflow configuration and records management.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, and other systems; support data traceability.
• Prepare and execute functional and integration test scripts; maintain traceability between requirements, risks, and test evidence.

Kenntnisse

Quality-domain expertise

Digital QMS

QA/QC and Lab integration

Quality data and integration

Delivery discipline

Technical communication

GxP & quality controls

Analytical judgment

Ausbildung

Bachelor’s degree in life sciences or related field

Tools

LIMS

eQMS/QMS platforms

APIs

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions for regulated environments.

You will work across QA, QC, laboratory, regulatory, IT, data, and technology teams, owning technical deliverables and guiding design, configuration, testing, validation, deployment, and adoption of quality workflows. Travel may be required, and a strong foundation in GxP controls is essential.