Senior Quality & Digital QMS Lead (Life Sciences)

EY; Providence (RI); Remote; USD 97.000 - 178.000; Vollzeit

Benefits dieser Stelle

Medical and dental coverage

Pension and 401(k)

Paid time off

Zusammenfassung

EY is seeking a Senior in Supply Chain Manufacturing Quality to join a client-facing team. You will connect QA/QC, laboratory, and manufacturing needs with deployable technology across the delivery lifecycle, from assessments to deployment and stabilization.

You will work with QA, QC, laboratory, regulatory, IT, data, and vendor teams to deliver compliant solutions, with focus on AI-enabled quality workflows and data integrity in GxP contexts.

Qualifikationen

• Bachelor's degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevantExperience in Life Sciences quality, QA/QC, or digital QMS.
• Experience with QA/QC, laboratory processes in regulated environments.
• Experience producing technical/delivery artifacts: requirements, data mappings, test scripts.

Aufgaben

• Assess quality and laboratory workflows, user needs, system interfaces, instrument and equipment data, and current-state pain points.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, quality-system controls, and acceptance criteria.
• Support design and implementation of quality-domain capabilities (deviations, CAPA, change control, audits, supplier quality, batch disposition).
• Design and improve digital-quality workflows using eQMS/QMS platforms and integration with enterprise systems.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other systems; support assays and OOS/OOT traceability.
• Develop and review quality data models, source-to-target mappings, data-quality rules, and contextualized datasets.
• Work with architects on interfaces, APIs, and secure data movement across sites.
• Prepare and execute functional and integration test scripts; maintain traceability between requirements and test evidence.
• Support deployment readiness, training, and handover with clear documentation.
• Partner with client QA/validation teams to address GxP/GMP, data integrity, electronic records, and audit trails.
• Integrate data to identify recurring events, support root-cause analysis, and improve decision making.
• Contribute to governed AI applications for Quality with human-in-the-loop review.
• Communicate progress and risks to client counterparts and engagement leads.

Kenntnisse

Quality-domain expertise

Digital QMS skills

QA/QC integration

Quality data & integration

Delivery discipline

Technical communication

GxP controls

Analytical judgment

Ausbildung

Bachelor's degree in life sciences/quality/engineering/CS

Tools

LIMS

eQMS/QMS platforms

MES

ERP

Laboratory instruments interfaces

Jobbeschreibung

EY is seeking a Senior in Supply Chain Manufacturing Quality to join a client-facing team. You will connect QA/QC, laboratory, and manufacturing needs with deployable technology across the delivery lifecycle, from assessments to deployment and stabilization.

You will work with QA, QC, laboratory, regulatory, IT, data, and vendor teams to deliver compliant solutions, with focus on AI-enabled quality workflows and data integrity in GxP contexts.