Life Sciences Quality Transformation Manager

EY

Alpharetta (GA)

Remoto

USD 128.000 - 267.000

Tempo pieno

8 giorni fa

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Vantaggi offerti da questo lavoro

Total Rewards package
Medical and dental coverage
Pension and 401(k)

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams to strengthen quality systems across manufacturing and laboratory operations. This role blends practical quality knowledge with digital QMS, data, and AI to deliver solutions in regulated environments.

As a techno-functional delivery leader, you will drive assessment, requirements, design, implementation, testing, and stabilization of programs with senior engagement

Competenze

  • Bachelor's degree in life sciences, engineering, quality, or related field.
  • At least 7 years of Life Sciences Manufacturing Quality, QA/QC, or related experience.
  • Experience leading client-facing quality/tech workstreams through design and deployment.
  • Experience in regulated manufacturing environment (GxP/GMP).
  • Willingness to travel 80–100% as needed.

Mansioni

  • Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
  • Assess current-state quality processes, data flows, and site constraints.
  • Translate quality needs into requirements, designs, and acceptance criteria.
  • Develop designs for deviations, CAPA, change control, audits, and inspection readiness.
  • Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP.
  • Define data mappings and quality reporting for analytics and AI.

Conoscenze

Quality management
Client-facing leadership
Data analytics
Workshop facilitation
Delivery leadership
AI in quality

Formazione

Bachelor's degree in life sciences or engineering

Strumenti

eQMS/QMS platforms
LIMS
MES/MOM
ERP systems
Document management

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams to strengthen quality systems across manufacturing and laboratory operations. This role blends practical quality knowledge with digital QMS, data, and AI to deliver solutions in regulated environments.

As a techno-functional delivery leader, you will drive assessment, requirements, design, implementation, testing, and stabilization of programs with senior engagement

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