Senior Quality & Digital QMS Lead – Supply Chain

EY; Irvine (CA); Remoto; USD 97.000 - 178.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k)

Paid time off

Descrizione del lavoro

EY’s Senior in Supply Chain Manufacturing Quality role partners with pharmaceutical, biotechnology, and medical-device clients to connect Quality Assurance, Quality Control, laboratory and manufacturing needs with deployable technology. You will contribute across the delivery lifecycle, from requirements through validation and deployment.

You will work with QA/QC, laboratory, regulatory, IT, data, and provider teams to own deliverables, resolve issues, and translate workflows into compliant

Competenze

• To qualify, a bachelor’s degree in life sciences, quality, engineering, information systems, or related field is required.
• At least 3 years of relevant Life Sciences quality, QA/QC, or laboratory systems experience.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience producing technical or functional delivery artifacts such as requirements, data mappings, or validation evidence.
• Ability to travel as needed (up to 100%).
• Authorized to work in the U.S. without sponsorship.

Mansioni

• Assess quality and laboratory workflows, user needs, data interfaces, and pain points.
• Document process flows, requirements, data mappings, and acceptance criteria for digital quality solutions.
• Support design and implementation of digital quality workflows spanning deviations, CAPA, change control, and batch release.
• Design digital-quality workflows with eQMS/QMS platforms, records management, approvals, and reporting.
• Integrate QA/QC and laboratory data across LIMS, MES, ERP, and related systems; support AI-enabled quality tools.

Descrizione del lavoro

EY’s Senior in Supply Chain Manufacturing Quality role partners with pharmaceutical, biotechnology, and medical-device clients to connect Quality Assurance, Quality Control, laboratory and manufacturing needs with deployable technology. You will contribute across the delivery lifecycle, from requirements through validation and deployment.

You will work with QA/QC, laboratory, regulatory, IT, data, and provider teams to own deliverables, resolve issues, and translate workflows into compliant