Senior Life Sciences Quality & Supply Chain Lead

EY; Boca Raton (FL); Remote; USD 97,000 - 195,000; Full time

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital solutions for regulated quality environments across pharma, biotech, and medical devices. You will connect QA/QC, laboratory, manufacturing, and IT teams to deliver end-to-end quality systems aligned with GxP.

You’ll own deliverables from requirements to deployment, support validation, and contribute to AI-enabled quality investigations with governance and human-in-the-loop oversight.

Qualifications

• A bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or a related discipline.
• At least 3 years of relevant experience in Life Sciences quality, Quality Assurance, Quality Control, laboratory systems, digital QMS, systems implementation, technology consulting, or a related field.
• Experience with quality, laboratory, or manufacturing processes in a pharmaceutical, biotechnology, medical-device, or comparably regulated environment.
• Experience with one or more core quality processes, such as deviations, investigations, CAPA, change control, complaints, audits, supplier quality, batch disposition, release, or quality risk management.
• Experience producing technical or functional delivery artifacts, such as requirements, process maps, data mappings, interface specifications, configuration documents, test scripts, validation evidence, or deployment materials.
• Experience collaborating with quality, laboratory, operational, and technical delivery teams to investigate requirements, resolve issues, or implement a solution.

Responsibilities

• 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.

Skills

Quality-domain expertise

Digital QMS skills

QA/QC and laboratory integration

Quality data and integration

Delivery discipline

Technical communication

GxP and quality-system controls

Analytical judgment

Education

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

Tools

LIMS

eQMS/QMS platforms

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital solutions for regulated quality environments across pharma, biotech, and medical devices. You will connect QA/QC, laboratory, manufacturing, and IT teams to deliver end-to-end quality systems aligned with GxP.

You’ll own deliverables from requirements to deployment, support validation, and contribute to AI-enabled quality investigations with governance and human-in-the-loop oversight.