Senior Quality & Digital QMS Lead, Life Sciences

EY; New York (NY); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension and 401(k)

Paid time off

Zusammenfassung

EY in the United States seeks a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology for regulated environments. You will design and verify digital quality workflows, support validation and data integrity, and collaborate with cross‑functional teams on AI‑enabled quality solutions while ensuring GxP compliance.

You will own deliverables, resolve issues, and advise on compliant, traceable designs across QA, QC, and

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevant experience in Life Sciences quality, QA, QC, laboratory systems, digital QMS, or related field.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience producing technical/delivery artifacts such as requirements, process maps, data mappings, or test scripts.

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 acceptance criteria for digital quality solutions.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integrate with enterprise systems.
• Connect QA/QC and lab processes across LIMS, eQMS/QMS, MES, ERP and other data systems.
• Prepare and execute functional and integration test scripts and maintain traceability between requirements and test evidence.

Kenntnisse

Quality-domain expertise

Digital QMS

QA/QC and lab integration

Quality data & integration

Delivery discipline

Technical communication

GxP & quality-system controls

Analytical judgment

Ausbildung

Bachelor’s degree in life sciences/quality/engineering/info systems/computer science/supply chain

Jobbeschreibung

EY in the United States seeks a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable technology for regulated environments. You will design and verify digital quality workflows, support validation and data integrity, and collaborate with cross‑functional teams on AI‑enabled quality solutions while ensuring GxP compliance.

You will own deliverables, resolve issues, and advise on compliant, traceable designs across QA, QC, and