Life Sciences Quality Transformation Manager

EY; Hartford (CT); On-site; USD 128,000 - 257,000; Full time

Benefits offered by this job

Total Rewards benefits

Job summary

EY seeks a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems, data, and lab operations. You will drive delivery from assessment to stabilization, focusing on inspection readiness and product quality in regulated settings.

You will work with pharma, biotech, and medical-device clients, translating needs into functional designs, coordinating specialists, and ensuring governance, data integrity, and AI-enabled insights

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• 7+ years of relevant Life Sciences Manufacturing Quality experience including QA/QC or technology.
• Experience leading client-facing quality, digital, data, or tech workstreams through design and deployment phases.
• Experience in pharmaceutical/biotech/medical-device regulated environments.
• Translate quality needs into process, data, and testing deliverables; coordinate contributors.
• Knowledge of GxP/GMP and electronic records/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 design, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, and quality reporting.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab informatics systems.
• Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
• Deliver quality analytics and AI use cases with governance and controls.
• Ensure compliance with audit trails, traceability, and validation requirements.

Skills

Life Sciences Manufacturing Quality

Quality systems

Data analysis

AI use cases

Education

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

Tools

eQMS/QMS

LIMS

MES/MOM

ERP

Job description

EY seeks a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems, data, and lab operations. You will drive delivery from assessment to stabilization, focusing on inspection readiness and product quality in regulated settings.

You will work with pharma, biotech, and medical-device clients, translating needs into functional designs, coordinating specialists, and ensuring governance, data integrity, and AI-enabled insights