Life Sciences Quality Transformation Manager

EY

Raleigh (NC)

On-site

USD 128,000 - 257,000

Full time

8 days ago

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Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY seeks a Client-facing Life Sciences Manufacturing Quality Manager to drive technology-enabled transformation across QA/QC and quality systems in regulated environments. You will lead quality improvements, data integrity, and inspection readiness across manufacturing and laboratory operations.

This techno-functional role blends quality expertise with digital QMS, data analytics, and AI use cases, guiding teams from assessment through design and deployment with senior EY leadership oversight.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, or related discipline.
At least 7 years of relevant Life Sciences Manufacturing Quality or related field experience.
Experience leading client-facing quality/ digital/ data workstreams through design and deployment phases.
Experience in pharmaceutical/ biotech/ medical-device regulated environments.
Ability to 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 and data flows.
Translate priorities into designs, requirements, and acceptance criteria.
Develop functional designs for deviations, CAPA, change control, audits and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and related systems.