Senior Quality & Supply Chain Lead – Digital QMS (Remote)

EY; New Orleans (LA); Remote; USD 97,000 - 195,000; Full time

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, build, test, and deploy digital quality solutions for regulated environments. You will bridge QA/QC, laboratory, and manufacturing domains with modern data platforms, supporting AI-enabled quality workflows.

You will collaborate with QA, QC, regulatory, IT, and client teams to deliver end-to-end quality capabilities, including deviations, CAPA, change control, and batch release, while traveling as needed to serve

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevant experience in Life Sciences quality, QA, QC, laboratory systems, digital QMS, systems implementation, or related field.
• Experience with quality processes such as deviations, investigations, CAPA, change control, complaints, audits, supplier quality, batch disposition, release, or quality risk management.
• Experience producing technical 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 implement solutions.
• Ability to travel as needed; travel may range from 80-100%.
• Candidates must be legally authorized to work in the U.S. without employer sponsorship.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, data, and pain points through interviews, workshops, and data review.
• Document process flows, user stories, functional requirements, data mappings, interface requirements, quality controls, and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities spanning deviations, investigations, CAPA, change control, audits, batch disposition, release, and risk management.
• Design and improve digital-quality workflows using eQMS/QMS platforms, including workflow configuration, records management, approvals, escalation paths, and reporting.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, chromatography and other systems; support data systems connectivity.
• Develop and review quality data models, data quality rules, and contextualized datasets relating quality events to products and processes.
• Work with architects on interface specifications, APIs, and secure data movement across environments.
• Prepare and execute functional and integration test scripts, maintain traceability between requirements, risks, controls, and tests.
• Support deployment readiness, training, and handover with clear documentation.
• Partner with client quality and validation teams to prepare or review GxP, data integrity, electronic records, validation, and audit trails documentation.
• Integrate data to identify trends, support root-cause analysis, and improve quality decisions.
• Contribute to governed AI applications for quality with human-in-the-loop governance and controls.
• Communicate progress, risks, dependencies, and next steps to client counterparts and leads.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Quality data

Delivery discipline

Technical communication

GxP and quality-system controls

Analytical judgment

Education

Bachelor’s degree in life sciences/quality/engineering

Tools

LIMS

Lab data systems

Chromatography data systems

Stability management

Laboratory instruments integration

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to help design, build, test, and deploy digital quality solutions for regulated environments. You will bridge QA/QC, laboratory, and manufacturing domains with modern data platforms, supporting AI-enabled quality workflows.

You will collaborate with QA, QC, regulatory, IT, and client teams to deliver end-to-end quality capabilities, including deviations, CAPA, change control, and batch release, while traveling as needed to serve