Life Sciences Quality Transformation Manager

EY; Boston (MA); Remote; USD 140,000 - 190,000; Full time

Job summary

EY is seeking a Manager for Supply Chain Operations in Life Sciences Manufacturing Quality. You will lead technology-enabled transformation workstreams that strengthen quality systems, compliance, audit readiness, and product quality across manufacturing and laboratory operations.

You will collaborate with pharmaceutical, biotech, and medical-device clients to design and implement quality capabilities, integrate eQMS/QMS, LIMS, ERP, and data systems, and drive data-driven quality improvements in

Qualifications

• A bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, 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.
• Experience working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
• Experience translating quality-domain needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
• Practical understanding of GxP/GMP and related documentation, change-control, data-integrity, and electronic-records-and-signatures considerations.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into functional designs, requirements, and acceptance criteria.
• Develop functional designs for deviations, CAPA, change control, audits, supplier quality, and batch release.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and document-management systems.
• Define data mappings and data-quality controls for quality reporting and AI use cases.
• Support AI-enabled quality analytics through data readiness and governance.
• Ensure compliance with GxP/GMP, electronic-records-and-signatures, and validation considerations.
• Oversee testing, deployment readiness, training, and handover for the workstream.
• Facilitate cross-functional sessions and manage scope, schedule, and risks.

Skills

Quality systems

Data analytics

Regulatory familiarity

Stakeholder management

Workshop facilitation

Technical collaboration

Education

Bachelor's degree in life sciences, engineering, quality, supply chain, information systems, or related discipline

Tools

eQMS/QMS platforms

LIMS

ERP systems

Data integration

Job description

EY is seeking a Manager for Supply Chain Operations in Life Sciences Manufacturing Quality. You will lead technology-enabled transformation workstreams that strengthen quality systems, compliance, audit readiness, and product quality across manufacturing and laboratory operations.

You will collaborate with pharmaceutical, biotech, and medical-device clients to design and implement quality capabilities, integrate eQMS/QMS, LIMS, ERP, and data systems, and drive data-driven quality improvements in