Senior Quality & Digital Supply Chain (QMS)

EY; Austin (TX); Remote; USD 97,000 - 178,000; Full time

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA, QC, laboratory, manufacturing, and IT with deployable digital solutions for regulated environments. You will own technical delivers across the lifecycle, from assessments to validation and deployment, collaborating with QA, IT and client teams.

The role emphasizes GxP/GMP, data integrity, AI-enabled quality enhancements, and end-to-end traceability, with travel as needed and a focus on delivering compliant, tested

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, CS, supply chain or related discipline.
• At least 3 years of Life Sciences quality experience in regulated environments.
• Experience with deviations, investigations, CAPA, change control, complaints, audits, supplier quality, batch disposition or release.
• Experience producing requirements, process maps, data mappings, interface specifications, validation or deployment materials.
• Experience collaborating with QA, QC, operational and technical delivery teams.
• Willingness to travel 80–100%.

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 and acceptance criteria for digital quality solutions.
• Support design and implementation of quality-domain capabilities spanning deviations, CAPA, change control, audits, supplier quality, batch release and quality risk management.
• Design digital-quality workflows using eQMS/QMS platforms, including records management, approvals, escalation, reporting and system integration.
• Integrate QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP and related lab data systems; support data traceability and analytics.
• Prepare and execute test scripts, record defects, support resolution and retesting, and maintain traceability between requirements, risks, controls and test evidence.
• Support deployment readiness, training, and handover with clear documentation and issue resolution.
• Collaborate with client quality and validation teams to address GxP/GMP, data integrity, electronic records and signatures, audit trails, and end-to-end traceability.
• Contribute to AI-enabled quality workflows with governance and human-in-the-loop review.
• Communicate progress, risks, and next steps to client counterparts and engagement leaders.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Data integration

Requirements docs

Testing & validation

AI in quality

Education

Bachelor’s degree in life sciences or related field

Tools

LIMS

eQMS/QMS platforms

APIs

Data modelling

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA, QC, laboratory, manufacturing, and IT with deployable digital solutions for regulated environments. You will own technical delivers across the lifecycle, from assessments to validation and deployment, collaborating with QA, IT and client teams.

The role emphasizes GxP/GMP, data integrity, AI-enabled quality enhancements, and end-to-end traceability, with travel as needed and a focus on delivering compliant, tested