Life Sciences Quality Transformation Manager

EY; Boca Raton (FL); On-site; USD 128,000 - 267,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Job summary

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead client-facing workstreams across life sciences quality, QA/QC, and lab operations. The role focuses on transforming quality systems with digital and AI-enabled solutions, balancing regulatory requirements with practical implementation across manufacturing and laboratory environments.

You will coordinate with quality, IT, data, and vendor teams, ensuring compliance, data integrity, and timely delivery of capabilities such as

Qualifications

• 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, technology, or related field.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation phase.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Ability to translate quality needs into process and data deliverables and coordinate contributors.
• Understanding of GxP/GMP, data integrity, and electronic records considerations.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear plans and deliverables.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into designs, requirements, and acceptance criteria with measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, supplier quality, and batch release.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and related systems.
• Define data mappings and data-quality controls for reporting, analytics, and AI use cases.
• Support AI-enabled investigations, anomaly detection, and root-cause analysis with governance.
• Ensure regulatory compliance with audit trails, validation, and data-traceability requirements.
• Oversee testing, deployment readiness, training, and cutover support for the workstream.
• Facilitate cross-functional sessions and manage scope, schedule, and risks.

Skills

Quality management

Data integrity

AI in quality

Project leadership

Education

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

Tools

eQMS/QMS platforms

LIMS

MES/MOM

ERP

Job description

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead client-facing workstreams across life sciences quality, QA/QC, and lab operations. The role focuses on transforming quality systems with digital and AI-enabled solutions, balancing regulatory requirements with practical implementation across manufacturing and laboratory environments.

You will coordinate with quality, IT, data, and vendor teams, ensuring compliance, data integrity, and timely delivery of capabilities such as