Life Sciences Quality Transformation Manager

EY; Providence (RI); Remoto; USD 128.000 - 257.000; 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, quality systems, and regulatory readiness in the US. You will coordinate cross-functional teams, translate quality needs into actionable requirements, and drive data-driven improvements with AI use cases.

The role focuses on right-first-time execution, CAPA effectiveness, and inspection readiness, while aligning with GxP/GMP requirements and validated environments.

Competenze

• Bachelor's degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant experience in Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data and AI, technology consulting, or a related field.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation or deployment phase.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Define and review data mappings, master-data needs, interface specifications, and data-quality controls for quality reporting and AI use cases.
• Oversee integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and document-management systems.

Conoscenze

Quality systems

Data analytics

Cross-functional collaboration

Formazione

Bachelor's degree in life sciences or related

Strumenti

eQMS/QMS

LIMS

ERP systems

APIs

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, quality systems, and regulatory readiness in the US. You will coordinate cross-functional teams, translate quality needs into actionable requirements, and drive data-driven improvements with AI use cases.

The role focuses on right-first-time execution, CAPA effectiveness, and inspection readiness, while aligning with GxP/GMP requirements and validated environments.