Senior Life Sciences Quality & Digital QMS Lead

EY; Birmingham (AL); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension and 401(k)

Paid time off options

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing with deployable technology. You’ll work across quality processes, from assessments to design, validation, and deployment, supporting AI-enabled quality workflows in regulated environments.

You will collaborate with QA/QC, regulatory, IT, and data teams to deliver compliant, traceable solutions and contribute to end-to-end traceability and quality decisions.

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or a related discipline.
• 3+ years of relevant experience in Life Sciences quality, Quality Assurance, Quality Control, laboratory systems, digital QMS, systems implementation, technology consulting, or a related field.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience with core quality processes (deviations, investigations, CAPA, change control, audits, supplier quality, release).
• Experience delivering requirements, process maps, data mappings, interface specs, validation or deployment materials.

Aufgaben

• 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, and quality-system controls.
• Support design and implementation of quality-domain capabilities including deviations, CAPA, change control, audits, and inspection readiness.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with enterprise systems.
• Integrate QA/QC and laboratory data across LIMS, eQMS/QMS, MES, ERP, and related platforms; support traceability.

Kenntnisse

Quality-domain expertise

Digital QMS

QA/QC integration

Quality data integration

Delivery discipline

Technical communication

GxP controls

Analytical judgment

Ausbildung

Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline

Tools

LIMS

eQMS/QMS platforms

MES

ERP

data analytics tools

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing with deployable technology. You’ll work across quality processes, from assessments to design, validation, and deployment, supporting AI-enabled quality workflows in regulated environments.

You will collaborate with QA/QC, regulatory, IT, and data teams to deliver compliant, traceable solutions and contribute to end-to-end traceability and quality decisions.