Senior Quality & Digital QMS Operations Lead

EY; Denver (CO); Remote; USD 97,000 - 195,000; Full time

Benefits offered by this job

Medical insurance

Dental coverage

401(k)

Paid time off

Job summary

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing processes with deployable digital solutions. You will lead design, configuration, testing, validation, deployment, and adoption of quality workflows across pharma, biotech, and medical-device clients.

You will collaborate with QA, QC, regulatory, IT, data, and technology teams, owning deliverables, resolving issues, and shaping compliant designs and tests for end-to-end traceability.

Qualifications

• Bachelor’s degree in life sciences, quality, engineering, information systems, supply chain, or a related discipline.
• At least 3 years of Life Sciences quality, QA/QC, or regulated environment experience.
• Experience with quality, laboratory, or manufacturing processes in pharma/biotech/medical-device settings.
• Experience with deviations, CAPA, change control, audits, or quality risk management.
• Willingness to travel 80–100% as needed.
• Authorized to work in the U.S. without employer sponsorship.

Responsibilities

• Assess quality and lab workflows, user needs, system interfaces, and data points.
• Document process flows, user stories, requirements, and data mappings for digital quality solutions.
• Support quality-domain capabilities across deviations, investigations, CAPA, change control, and release workflows.
• Design and improve digital-quality workflows with eQMS/QMS platforms and integrations.
• Connect QA/QC and laboratory processes across LIMS, eQMS/QMS, MES, ERP, and related systems.
• Develop data models, source-to-target mappings, and data-quality rules.
• Collaborate on interfaces, APIs, and instrument connectivity for secure data movement.
• Prepare functional and integration test scripts and maintain traceability.

Skills

Quality-domain expertise

Digital QMS

QA/QC integration

Data modeling

Requirements docs

Testing & validation

GxP knowledge

AI in quality

Education

Bachelor’s degree in life sciences or related

Tools

LIMS

eQMS/QMS

MES

ERP

APIs

Job description

EY is seeking a Senior in Supply Chain Manufacturing Quality to connect QA/QC, laboratory, and manufacturing processes with deployable digital solutions. You will lead design, configuration, testing, validation, deployment, and adoption of quality workflows across pharma, biotech, and medical-device clients.

You will collaborate with QA, QC, regulatory, IT, data, and technology teams, owning deliverables, resolving issues, and shaping compliant designs and tests for end-to-end traceability.