Life Sciences Quality Transformation Lead (AI-Enabled)

EY; Charleston (WV); On-site; USD 128,000 - 257,000; 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 Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled workstreams across QA/QC, laboratory operations, and manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while coordinating with eQMS, LIMS, MES, and ERP systems.

The role blends practical quality-domain expertise with digital QMS, data, AI, and delivery skills to translate quality needs into scalable solutions in regulated environments.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant Life Sciences Manufacturing Quality experience in quality technology, industrial data and AI, or related fields.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate quality needs into process designs, requirements, and acceptance criteria with measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, and inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab informatics systems.
• Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
• Deliver quality analytics and AI use cases with governance and human-in-the-loop review.
• Ensure compliance with GxP/GMP and electronic-records-and-signatures requirements in workstream outputs.
• Oversee testing, deployment readiness, training, and handover for the workstream.
• Facilitate cross-functional sessions and manage scope, schedule, resources, and risks.

Skills

Quality management

GxP/GMP

Data analytics

AI in quality

Education

Bachelor's degree in life sciences

Tools

eQMS/QMS

LIMS

MES/MOM

ERP

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled workstreams across QA/QC, laboratory operations, and manufacturing. You will drive quality-system performance, data integrity, and inspection readiness while coordinating with eQMS, LIMS, MES, and ERP systems.

The role blends practical quality-domain expertise with digital QMS, data, AI, and delivery skills to translate quality needs into scalable solutions in regulated environments.