Life Sciences Quality Transformation Lead

EY

Huntsville (AL)

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) plans

Paid time off options

Job summary

EY in the United States is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformation across manufacturing and laboratory operations. You will shape quality systems, data integrity, audits, and inspection readiness while coordinating with QA/QC, IT, and vendor teams.

You will drive design, implementation, testing and adoption of quality capabilities, including deviations, CAPA, change control and analytics.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related field.
At least 7 years of relevant Life Sciences Manufacturing Quality, QA/QC, or related experience.
Experience leading a client-facing quality/ digital/ data workstream through design and deployment.
Experience in regulated environments (pharma/biotech/medical devices) with GxP context.
Ability to translate quality needs into process, data, and testing deliverables.
Willingness to travel 80-100% as required.

Responsibilities

Lead client-facing workstreams with ownership of plans, deliverables, risks and outcomes.
Assess current-state quality processes, data flows and site constraints via workshops and data analysis.
Translate priorities into design specs, acceptance criteria and measurable improvements.
Develop functional designs for deviations, CAPA, change control, audits, and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and laboratory systems.
Define data mappings and quality reporting requirements for analytics and AI use cases.