Life Sciences Quality Delivery Manager

EY; Pittsburgh (Allegheny County); A distancia; USD 128.000 - 267.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage

Pension and 401(k) plans

Paid time off and holidays

Global mobility opportunities

Descripción de la vacante

EY in the United States is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads tech-enabled transformation across quality systems and manufacturing operations. You will guide delivery from assessment through design, testing, and stabilization, focusing on data integrity and inspection readiness.

You’ll collaborate with pharma, biotech, and medical-device clients, coordinate cross-functional teams, and ensure compliant solutions.

Formación

• Bachelor’s degree in life sciences, engineering, quality, supply chain, or related field.
• At least 7 years in Life Sciences Manufacturing Quality or related field.
• Experience leading a client-facing quality, digital, data, or technology workstream.
• Experience in pharma/biotech/medical-device or other regulated manufacturing.
• Ability to translate quality needs into process, data, and testing deliverables.
• Knowledge of GxP/GMP, data integrity, and e-signatures relevant to digital quality.
• Willingness to travel as needed; travel could be 80–100%.
• Eligible to work in the U.S. without sponsorship.

Responsabilidades

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and deliverables.
• Assess current-state quality processes, data flows, gaps, and site constraints via workshops and analysis.
• Translate priorities into designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, and inspection-readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems.
• Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
• Oversee testing, deployment readiness, training, and cutover support for your workstream.
• Coach junior team members and capture reusable requirements and patterns.

Conocimientos

Quality transformation leadership

Data analytics

Workshop facilitation

GxP/GMP familiarity

Stakeholder management

AI/data analytics awareness

Educación

Bachelor's degree in life sciences, engineering, quality, supply chain, information systems or related discipline

Herramientas

eQMS/QMS

LIMS

MES/MOM

ERP

Document management

Descripción del empleo

EY in the United States is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads tech-enabled transformation across quality systems and manufacturing operations. You will guide delivery from assessment through design, testing, and stabilization, focusing on data integrity and inspection readiness.

You’ll collaborate with pharma, biotech, and medical-device clients, coordinate cross-functional teams, and ensure compliant solutions.