Senior Life Sciences Quality & Digital QMS Lead

EY; Atlanta (GA); Remote; USD 97.000 - 203.000; Vollzeit

Benefits dieser Stelle

Medical and dental benefits

Pension and 401(k)

Paid time off

Zusammenfassung

EY seeks a Senior in Supply Chain Manufacturing Quality to partner with pharmaceutical, biotechnology, and medical-device clients. This role bridges QA/QC, laboratory, and manufacturing needs with deployable digital solutions across the quality domain, data models, and AI-enabled workflows.

You will influence design, validation, deployment, and adoption of digital quality systems, ensuring alignment with GxP, data integrity, and end-to-end traceability across enterprise data.

Qualifikationen

• Bachelor's degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.
• At least 3 years of relevant Life Sciences quality, QA/QC, or laboratory systems experience.
• Experience with quality processes: deviations, CAPA, change control, audits, supplier quality, batch disposition, release.
• Experience producing requirements, process maps, data mappings, interface specs, validation evidence, deployment materials.
• Knowledge of GxP/GMP, data integrity, electronic records and signatures, controlled change, audit trails, traceability.
• Ability to travel 80-100% as needed.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, and data points to identify pain points.
• Document process flows, user stories, functional requirements, data mappings, and interface requirements.
• Design digital‑quality workflows and integrate QA/QC processes across LIMS, eQMS/QMS, MES, and ERP.
• Prepare and execute functional and integration test scripts and maintain traceability to requirements and controls.
• Support deployment readiness, user training, and handover with clear documentation.
• Collaborate with QA, validation, and client teams to ensure compliant, traceable solutions.

Kenntnisse

Quality-domain expertise

Digital QMS

QA/QC integration

Data modeling

Requirements gathering

Documentation

Technical communication

GxP knowledge

Analytical judgment

Travel willingess

Ausbildung

Bachelor's degree in life sciences or related

Tools

LIMS

eQMS/QMS

MES

ERP

AI-enabled QA

Jobbeschreibung

EY seeks a Senior in Supply Chain Manufacturing Quality to partner with pharmaceutical, biotechnology, and medical-device clients. This role bridges QA/QC, laboratory, and manufacturing needs with deployable digital solutions across the quality domain, data models, and AI-enabled workflows.

You will influence design, validation, deployment, and adoption of digital quality systems, ensuring alignment with GxP, data integrity, and end-to-end traceability across enterprise data.