Life Sciences Quality Transformation Manager

EY

Arlington (VA)

A distancia

USD 128.000 - 257.000

Jornada completa

Hace 8 días

Una candidatura completa en un minuto

Currículum y carta de presentación personalizados, listos para enviar.

Supera los filtros ATS

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Descripción de la vacante

EY is seeking a Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems, data and AI use cases for pharma/biotech/manufacturing clients. You will own workstreams from assessment to stabilization, ensuring quality-system performance, data integrity, and inspection readiness.

The role requires 7+ years in Life Sciences Quality, experience in regulated environments, and travel up to 100%.

Formación

Bachelor’s degree in life sciences or related discipline.
At least 7 years of Life Sciences Manufacturing Quality experience.
Experience leading client-facing quality, digital, or data workstreams through design and deployment.
Experience in regulated pharma/biotech/medical-device environments.
Ability to translate quality needs into processes, data, and testing deliverables.
Willingness to travel 80–100%.

Responsabilidades

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation, with ownership of plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops and data analysis.
Translate priorities such as right-first-time execution, cycle-time reduction, deviation/nonconformance reduction, CAPA effectiveness, and inspection readiness into designs, requirements, acceptance criteria, and measurable improvements.
Develop functional designs for deviations/nonconformances, CAPA, change control, audits and inspection readiness, supplier quality, batch disposition/release, and quality risk management.
Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and laboratory-instrument systems with architects and cybersecurity teams.
Define and review data mappings, master-data needs, interface specifications, and data-quality controls for quality reporting, analytics, and AI use cases.
Help deliver quality analytics and AI use cases by assessing data readiness, workflow fit, evaluation criteria, and governance.
Work with validation teams to reflect GxP/GMP, data-integrity, electronic-records-and-signatures requirements in workstream deliverables.
Oversee configuration activities, testing, deployment readiness, training, cutover support, hypercare, and handover.
Facilitate sessions across quality, QA/QC, manufacturing, laboratory, IT, data, and vendor teams.