Life Sciences Quality Transformation Manager

EY; Southfield (MI); Remote; USD 128,000 - 235,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off options

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems and operations in a regulated environment. You will own workstreams from assessment through design, implementation, testing, adoption, and stabilization, emphasizing data integrity and inspection readiness.

You will coordinate with quality, QA/QC, manufacturing, laboratory, IT, and vendor teams, translating quality needs into actionable requirements while

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 client-facing quality/ digital workstreams through design and deployment.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Translate quality needs into process, data, and testing deliverables.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
• Assess current-state quality processes, data flows, and system landscapes.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, and audits/inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab informatics systems.
• Define data mappings and data-quality controls for reporting and AI use cases.
• Oversee testing, deployment readiness, training, and handover for your workstream.
• Facilitate cross-functional sessions across quality, manufacturing, IT, and data teams.

Skills

Quality management

Data analytics

GxP/GMP knowledge

Quality tech & AI

Workshop facilitation

Education

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

Tools

eQMS/QMS platforms

LIMS

ERP

MES/MOM

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems and operations in a regulated environment. You will own workstreams from assessment through design, implementation, testing, adoption, and stabilization, emphasizing data integrity and inspection readiness.

You will coordinate with quality, QA/QC, manufacturing, laboratory, IT, and vendor teams, translating quality needs into actionable requirements while