Senior Quality & Digital QMS Lead - Supply Chain

EY; Chicago (IL); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension and 401(k)

Paid time off options

Zusammenfassung

EY seeks a Senior in Supply Chain Manufacturing Quality to join a globally connected team supporting pharmaceutical, biotech, and medical-device clients. You will connect QA/QC, laboratory, and manufacturing needs with deployable data-enabled quality workflows, across the delivery lifecycle from assessments to validation and deployment.

You will collaborate with QA, QC, IT, data teams, and validation groups, own deliverables, and mentor junior staff.

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 digital QMS.
• Experience with regulated pharma/biotech environments.
• Experience with quality processes such as deviations, CAPA, change control.
• Experience delivering requirements, data mappings, interface specifications, validation evidence.
• Willingness to travel 80-100%.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and equipment data, and current-state pain points through interviews, workshops, process observation, and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, quality-system controls, and acceptance criteria for digital quality solutions.
• Support the design and implementation of quality-domain capabilities spanning deviations and nonconformances, investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition and release, review by exception, and quality risk management.
• Design and improve digital-quality workflows using eQMS/QMS platforms, including workflow configuration, records management, approvals, escalation paths, effectiveness checks, reporting, and integration with adjacent enterprise systems.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other laboratory data systems, and relevant manufacturing platforms; support assays, stability programs, OOS/OOT traceability, deviation and CAPA analysis, and batch-review workflows.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC and laboratory integration

Quality data & integration

Delivery discipline

Ausbildung

Bachelor’s degree in life sciences, quality, engineering, information systems, or related

Tools

LIMS

eQMS/QMS platforms

Jobbeschreibung

EY seeks a Senior in Supply Chain Manufacturing Quality to join a globally connected team supporting pharmaceutical, biotech, and medical-device clients. You will connect QA/QC, laboratory, and manufacturing needs with deployable data-enabled quality workflows, across the delivery lifecycle from assessments to validation and deployment.

You will collaborate with QA, QC, IT, data teams, and validation groups, own deliverables, and mentor junior staff.