Life Sciences Quality Transformation Manager

EY; Detroit (MI); 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

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, manufacturing, and laboratory operations. The role focuses on strengthening quality systems, data integrity, and inspection readiness, partnering with senior leaders to deliver measurable improvements.

This techno-functional delivery position requires translating quality needs into actionable requirements and coordinating across eQMS/QMS, LIMS, MES/MOM, ERP, and

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.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one deployment phase.
• Experience in pharmaceutical/biotech/medical-device regulated environments.
• Ability to translate quality-domain needs into deliverables and coordinate contributors.
• Understanding of GxP/GMP and electronic-records-and-signatures considerations.

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 analyses.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, and other quality capabilities.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and instrumentation systems.
• Define data mappings and quality reporting data needs for analytics and AI use cases.
• Oversee validation, testing, deployment readiness, and handover for the workstream.
• Facilitate cross-functional sessions and manage scope, schedule, and risks.

Skills

Quality management

Client-facing

Delivery leadership

Data analytics

AI use cases

Education

Bachelor’s degree in life sciences/engineering/quality

Tools

eQMS/QMS

LIMS

MES/MOM

ERP

APIs

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, manufacturing, and laboratory operations. The role focuses on strengthening quality systems, data integrity, and inspection readiness, partnering with senior leaders to deliver measurable improvements.

This techno-functional delivery position requires translating quality needs into actionable requirements and coordinating across eQMS/QMS, LIMS, MES/MOM, ERP, and