Senior Quality & Digital QMS Lead – Life Sciences

EY; San Mateo (CA); Teletrabalho; USD 117 000 - 195 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Resumo da oferta

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions. You will work across life sciences clients to design, test, and deploy compliant quality workflows, including AI-enabled investigations and data governance.

You will collaborate with QA, QC, IT, and business teams, owning deliverables, and guiding interfaces, data models, validation, and deployment across GxP environments.

Qualificações

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or a related discipline.
• At least 3 years of relevant Life Sciences quality experience (QA, QC, lab systems, digital QMS, or related).
• Experience with regulated environments (pharma/biotech/medical devices).
• Experience delivering requirements, process maps, data mappings, interfaces, configurations, test scripts, validation or deployment materials.
• Collaborative with QA, QC, operational and technical teams; able to investigate requirements and resolve issues.

Responsabilidades

• Assess quality and laboratory workflows, user needs, system interfaces, data, and pain points via interviews and reviews.
• Document processes, requirements, data mappings, interfaces, and quality controls for digital quality solutions.
• Support design and implementation of quality-domain capabilities across deviations, CAPA, change control, audits, and release.
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with enterprise systems.
• Integrate QA/QC and lab data across LIMS, eQMS/QMS, MES, ERP and other data systems; support batch review and OOS/OOT traceability.
• Develop data models, mappings, data-quality rules, and contextual datasets relating quality events to products and processes.
• Collaborate with solution architects on interfaces, APIs, and secure data movement across environments.
• Prepare functional and integration test scripts; maintain traceability between requirements, risks, controls and tests.
• Support deployment readiness, training, and handover with clear documentation and issue response.
• Partner with client teams on GxP data integrity and audit trails; ensure end-to-end traceability.
• Contextualize data to identify trends, conduct root-cause analysis, and improve quality decisions.
• Contribute to governed AI applications for Quality with human-in-the-loop review and controls.
• Communicate progress and risks to client leads; coordinate with junior colleagues when needed.

Conhecimentos

Quality-domain expertise

Digital QMS skills

QA/QC and lab integration

Quality data & integration

Delivery discipline

Technical communication

GxP & quality controls

Analytical judgment

Formação académica

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

Ferramentas

LIMS

eQMS/QMS platforms

Descrição da oferta de emprego

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing needs with deployable digital solutions. You will work across life sciences clients to design, test, and deploy compliant quality workflows, including AI-enabled investigations and data governance.

You will collaborate with QA, QC, IT, and business teams, owning deliverables, and guiding interfaces, data models, validation, and deployment across GxP environments.