Senior Life Sciences Quality & Digital QMS Lead

EY; Montgomery (AL); Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with employer match

Paid time off

Job summary

EY seeks a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital quality solutions for regulated environments. You will bridge QA/QC, lab, and manufacturing with deployable technology, owning deliverables from requirements through validation and adoption.

You’ll work with cross-functional teams, integrate data across systems like LIMS and MES, and contribute to AI-enabled quality workflows while ensuring GxP compliance and end-to-end traceability.

Qualifications

• Bachelor’s degree in life sciences or related field.
• At least 3 years of relevant Quality within Life Sciences.
• Experience with regulated environments (pharma/biotech/medical devices).
• Experience delivering technical artifacts (requirements, mappings, test scripts).
• Willingness to travel 80-100% as needed.

Responsibilities

• Assess QA/QC and laboratory workflows with stakeholders.
• Document requirements, data mappings, and interface specs for digital quality solutions.
• Support design and implementation of quality-domain capabilities (CAPA, deviations, change control).
• Configure and prototype components; document design decisions for review.
• Prepare and execute test scripts; maintain traceability of requirements and validation evidence.
• Support deployment readiness and user training; respond to user issues.
• Collaborate with QA, validation, and IT teams to ensure compliance and traceability.
• Contribute to governed AI applications for quality with human-in-the-loop governance.

Skills

Quality-domain

Digital QMS

QA/QC integration

Data quality

Requirements & design docs

APIs and instrument connectivity

GxP/GMP

AI in quality

Education

Bachelor’s degree in life sciences, quality, engineering, information systems or related

Tools

LIMS

eQMS/QMS platforms

Lab data systems

Job description

EY seeks a Senior in Supply Chain Manufacturing Quality to design, build, test, and deploy digital quality solutions for regulated environments. You will bridge QA/QC, lab, and manufacturing with deployable technology, owning deliverables from requirements through validation and adoption.

You’ll work with cross-functional teams, integrate data across systems like LIMS and MES, and contribute to AI-enabled quality workflows while ensuring GxP compliance and end-to-end traceability.