Life Sciences Quality Transformation Manager

EY

Kansas City (MO)

Remote

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 in the United States is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformations across quality systems, data, AI, and delivery to improve compliance, inspection readiness, and product quality in regulated environments.

You will manage workstreams from assessment to implementation for pharmaceutical, biotech, and medical-device manufacturing, coordinating cross-functional teams and ensuring data integrity, CAPA effectiveness, and quality

Qualifications

Bachelor’s degree in life sciences or related field.
7+ years in Life Sciences Manufacturing Quality or related field.
Experience leading client-facing quality/digital workstreams.
Knowledge of GxP/GMP and electronic records considerations.
travel 80-100%.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes, data flows, and site constraints.
Translate quality needs into functional requirements and testable criteria.
Develop designs for deviations, CAPA, change control, and audits.
Coordinate integrations across eQMS/QMS, LIMS, MES/MOM, ERP.
Define data mappings and data-quality controls for reporting and AI use cases.
Oversee validation, testing, deployment readiness, and training.
Support governance, risk management, and stakeholder updates.