Senior Supply Chain Quality & Digital QMS Lead

EY; Beryl (WV); Remote; USD 97,000 - 178,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off options

Job summary

EY is seeking a Senior Life Sciences quality professional to design, test, and deploy digital QMS solutions across regulated quality, laboratory, and manufacturing environments. You will bridge QA/QC, IT, and business teams to deliver compliant, data-driven quality workflows.

You will own end-to-end delivery from requirements through validation, with emphasis on deviations, CAPA, data integrity, audits, and end-to-end traceability. Travel and client interactions are expected as needed.

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, computer science, supply chain, or related discipline.
• At least 3 years of relevant Life Sciences quality, QA, QC, laboratory systems, digital QMS, systems implementation, technology consulting, or related field.
• Experience with pharmaceutical/biotech/medical-device regulated environments.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, instrument data, and current-state pain points.
• Document process flows, user stories, functional requirements, data mappings, and interface requirements for digital quality solutions.
• Support design and implementation of quality-domain capabilities including deviations, CAPA, change control, complaints, audits, and inspection readiness.
• Design and improve digital-quality workflows with eQMS/QMS platforms, including configurations, records management, approvals, and reporting.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, and other data systems; support analysis and traceability.
• Develop data models, source-to-target mappings, data-quality rules, and contextualized datasets linking quality events to products and processes.
• Work with architects on interface specs, APIs, instrument connectivity, and secure data movement across environments.
• Prepare and execute test scripts, document defects, and maintain traceability to requirements and risks.
• Support deployment readiness, training, and handover with clear documentation and issue responses.
• Collaborate with client teams to prepare documentation addressing GxP/GMP, data integrity, electronic records, and end-to-end traceability.
• Contextualize data to identify trends, root-causes, and improve quality decision-making.
• Contribute to governed AI applications for Quality with human-in-the-loop governance.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Quality data integration

Delivery discipline

Technical communication

GxP/GMP controls

Analytical judgment

Education

Bachelor’s degree in life sciences/quality/engineering/IT/supply chain

Tools

LIMS

eQMS/QMS platforms

APIs and data interfaces

Job description

EY is seeking a Senior Life Sciences quality professional to design, test, and deploy digital QMS solutions across regulated quality, laboratory, and manufacturing environments. You will bridge QA/QC, IT, and business teams to deliver compliant, data-driven quality workflows.

You will own end-to-end delivery from requirements through validation, with emphasis on deviations, CAPA, data integrity, audits, and end-to-end traceability. Travel and client interactions are expected as needed.