Life Sciences Quality Transformation Lead

EY; Tallahassee (FL); Remoto; USD 128.000 - 235.000; Tempo pieno

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across manufacturing and laboratory operations. You will drive quality-system improvements, data integrity, and inspection readiness within regulated environments.

The role coordinates cross-functional teams, translating quality needs into actionable requirements and managing delivery across consulting and client stakeholders. Extensive travel is required.

Competenze

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant Life Sciences Manufacturing Quality experience.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation.
• Experience in pharmaceutical/biotech/medical-device regulated environments.
• Translate quality needs into process, data, and testing deliverables and coordinate contributors.
• Knowledge of GxP/GMP, data integrity, electronic records and signatures, and validation considerations.
• Ability to travel 80-100% as needed.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into functional designs, 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 document-management systems.
• Define data mappings and data-quality controls for reporting and AI use cases.
• Deliver quality analytics and AI use cases including anomaly detection and root-cause analysis.
• Ensure compliance with audit trails, traceability, and electronic-signatures.

Conoscenze

Quality systems knowledge

Data analysis

Workshop facilitation

Cross-functional collaboration

Formazione

Bachelor’s degree in life sciences, engineering, quality, or related field

Strumenti

eQMS/QMS platforms

LIMS

ERP systems

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across manufacturing and laboratory operations. You will drive quality-system improvements, data integrity, and inspection readiness within regulated environments.

The role coordinates cross-functional teams, translating quality needs into actionable requirements and managing delivery across consulting and client stakeholders. Extensive travel is required.