Senior Quality & Digital QMS Lead – Life Sciences

EY; New Brunswick (NJ); Remote; USD 97,000 - 178,000; Full time

Job summary

EY in the United States seeks a Senior in Supply Chain Manufacturing Quality to help pharmaceutical, biotech, and medical-device clients connect QA/QC, laboratory, and manufacturing with deployable digital solutions. You will own technical and functional deliverables from assessment through deployment, across QA, QC, IT, data, and client teams.

You will drive quality workflow design, data integration, validation, and continuous improvement while ensuring GxP compliance and traceability

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, or related discipline.
• At least 3 years of relevant Life Sciences quality, QA/QC, or related experience.
• Experience with quality, laboratory or manufacturing processes in regulated environments.
• Experience with deviations, investigations, CAPA, change control, audits, or quality risk management.
• Experience producing technical or functional delivery artifacts (requirements, maps, data mappings, interface specs, etc.).
• Ability to travel 80-100% as required.
• Candidates must be legally authorized to work in the U.S. without sponsorship.

Responsibilities

• Assess quality and laboratory workflows, user needs, system interfaces, and data pain points.
• Document process flows, user stories, requirements, data mappings, and quality-system controls.
• Support design and implementation of deviations, CAPA, change control, and batch release across QA/QC.
• Design and improve digital-quality workflows with eQMS/QMS platforms and integrations.
• Connect QA/QC and laboratory processes across LIMS, MES, ERP, and other systems.
• Develop data models and mappings linking quality events to products and processes.
• Collaborate with solution architects on interfaces, APIs, and data movement securely.
• Prepare functional and integration test scripts; document defects and evidence.
• Support deployment readiness, training, and handover with clients.
• Partner with validation teams on GxP documentation and data integrity.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Quality data & integration

Delivery discipline

Technical communication

GxP quality controls

Analytical judgment

Willingness to travel

Education

Bachelor’s degree in life sciences or related

Tools

LIMS

eQMS/QMS

APIs

Job description

EY in the United States seeks a Senior in Supply Chain Manufacturing Quality to help pharmaceutical, biotech, and medical-device clients connect QA/QC, laboratory, and manufacturing with deployable digital solutions. You will own technical and functional deliverables from assessment through deployment, across QA, QC, IT, data, and client teams.

You will drive quality workflow design, data integration, validation, and continuous improvement while ensuring GxP compliance and traceability