Senior Quality & Supply Chain, Digital QMS Expert

EY; San Jose (CA); Remote; USD 122.000 - 203.000; Vollzeit

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, lab, and manufacturing needs with deployable technology for regulated environments. You will engage with pharmaceutical, biotechnology, and medical-device clients to design, test, and deploy digital quality solutions across processes and data systems.

You will own technical deliverables, shape compliant designs, and guide teams through validation, deployment, and adoption, while aligning with GxP/ GMP controls and

Qualifikationen

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related field.
• At least 3 years of Life Sciences quality, QA/QC, or regulated lab experience.
• Experience with quality, laboratory, or manufacturing processes in regulated environments.
• Experience producing requirements, process maps, data mappings, interface specs, or validation materials.
• Ability to travel as needed; U.S. work authorization is required.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and equipment data, and pain points through interviews and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, controls, and acceptance criteria for digital quality solutions.
• Support design and implementation of deviations, CAPA, change control, audits, supplier quality, batch disposition, and release activities.
• Design and improve digital-quality workflows using eQMS/QMS platforms, including records management, approvals, escalation, and reporting.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography, and other lab data systems; support data traceability and CAPA analysis.
• Develop and review data models, source-to-target mappings, data-quality rules, and contextualized datasets relating quality events to products and processes.
• Collaborate on interface specs, API connectivity, and secure data movement across site and enterprise environments.
• Prepare functional/integration test scripts, log defects, and maintain traceability between requirements, controls, and tests.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC integration

Data modeling skills

Technical communication

GxP knowledge

Analytical judgment

AI in Quality concepts

Ausbildung

Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related

Tools

LIMS

eQMS/QMS

APIs

Data integration

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, lab, and manufacturing needs with deployable technology for regulated environments. You will engage with pharmaceutical, biotechnology, and medical-device clients to design, test, and deploy digital quality solutions across processes and data systems.

You will own technical deliverables, shape compliant designs, and guide teams through validation, deployment, and adoption, while aligning with GxP/ GMP controls and