Life Sciences Quality Transformation Manager

EY; Wichita (KS); Remoto; USD 128.000 - 267.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k)

Paid time off

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, data, and digital quality systems. You will guide workstreams from assessment through design, implementation, and stabilization in regulated environments.

The role focuses on quality-system performance, data integrity, and inspection readiness, collaborating with senior leaders and cross-functional teams to deliver tangible quality improvements.

Competenze

• Bachelor’s degree in life sciences, engineering, quality, or related discipline.
• At least 7 years of experience in Life Sciences Manufacturing Quality or related field.
• Experience leading client-facing quality/ digital/ data workstreams through design and deployment phases.
• Experience in pharmaceutical, biotechnology, medical-device, or regulated environments.
• Willingness to travel 80–100% as needed.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and analyses.
• Translate quality needs into requirements, 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, master data needs, and interfaces for quality reporting and AI use cases.
• Support AI use cases with data readiness assessment and governance.

Conoscenze

Quality management

Client-facing

Digital QMS

Data analytics

GxP knowledge

Formazione

Bachelor's degree in life sciences or related

Strumenti

LIMS

eQMS

Data platforms

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, data, and digital quality systems. You will guide workstreams from assessment through design, implementation, and stabilization in regulated environments.

The role focuses on quality-system performance, data integrity, and inspection readiness, collaborating with senior leaders and cross-functional teams to deliver tangible quality improvements.