Senior Quality & Digital QMS - Supply Chain

EY; Chattanooga (TN); Remote; USD 97.000 - 195.000; 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 own critical deliverables across the lifecycle, from assessments through validation and deployment.

You will design and improve digital-quality workflows using eQMS/QMS, integrate data across LIMS, MES, ERP, and laboratory systems, and advance AI-enabled quality initiatives while maintaining GxP compliance.

Qualifikationen

• Bachelor's degree in life sciences, quality, engineering, or related field.
• 3+ years of Life Sciences quality, QA, QC, or digital QMS experience.
• Experience with regulated environments (pharma/biotech/medical-device).
• Knowledge of deviations, investigations, CAPA, change control, audits, or risk management.
• Experience delivering requirements, process maps, data mappings, and test artifacts.
• Collaborative experience with QA, QC, operations, and technical teams.
• Ability to travel as needed (up to 100%).
• Authorized to work in the U.S. without sponsorship.

Aufgaben

• Assess quality and laboratory workflows, gather user needs and data points.
• Document processes, requirements, data mappings and interface specs.
• Design digital-quality workflows across eQMS/QMS platforms.
• Connect QA/QC and lab data across LIMS, MES, ERP and related systems.
• Prepare and execute validation, testing, and deployment activities.
• Support training, change management, and handover activities.
• Collaborate with client teams to ensure GxP/compliance and data integrity.
• Contribute to AI-enabled quality initiatives with governance.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC integration

Quality data & integration

Delivery discipline

Technical communication

GxP controls

Analytical judgment

Ausbildung

Bachelor's degree in life sciences or related

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 own critical deliverables across the lifecycle, from assessments through validation and deployment.

You will design and improve digital-quality workflows using eQMS/QMS, integrate data across LIMS, MES, ERP, and laboratory systems, and advance AI-enabled quality initiatives while maintaining GxP compliance.