Senior Life Sciences Quality Transformation Lead

EY

Charlotte (NC)

On-site

USD 128,000 - 257,000

Full time

8 days ago

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Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, data integrity, and inspection readiness in regulated environments. The role focuses on translating quality needs into actionable requirements and coordinating across eQMS/QMS, LIMS, MES/MOM, ERP, and analytics.

You will drive quality analytics, AI use cases, and validation activities, while working with senior leaders on program planning and delivery risks in a

Qualifications

  • Bachelor’s degree in life sciences, engineering, quality, or related field.
  • 7+ years in Life Sciences Manufacturing Quality or related tech/QA roles.
  • Experience leading client-facing quality/digital workstreams through design and deployment.
  • Understanding of GxP/GMP, data integrity, and electronic records considerations.

Responsibilities

  • Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
  • Assess current-state quality processes, data flows, and site constraints through workshops.
  • Translate priorities into design requirements and measurable improvements.
  • Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and lab informatics systems.
  • Define data mappings and quality reporting needs for analytics and AI use cases.
  • Oversee validation, testing, deployment readiness, training, and handover.

Skills

Quality domain knowledge
Workflow design
Data analytics
Stakeholder facilitation
AI use cases

Education

Bachelor’s degree in life sciences/engineering

Tools

LIMS
eQMS/QMS
GxP systems
AI data platforms

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, data integrity, and inspection readiness in regulated environments. The role focuses on translating quality needs into actionable requirements and coordinating across eQMS/QMS, LIMS, MES/MOM, ERP, and analytics.

You will drive quality analytics, AI use cases, and validation activities, while working with senior leaders on program planning and delivery risks in a

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