Life Sciences Quality Transformation Lead

EY; Tampa (FL); Remote; USD 128,000 - 267,000; Full time

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory and manufacturing operations. Focus on quality-system performance, data integrity and inspection readiness in regulated environments.

You will drive workstreams from assessment to design, implementation and stabilization, coordinating experts and ensuring measurable improvements while embracing AI and analytics.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems or related field.
• At least 7 years in Life Sciences Manufacturing Quality, QA/QC, or related tech and data roles.
• Experience leading a client-facing quality/digital workstream through design and deployment.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Ability to translate quality needs into process, data, and testing deliverables.
• Knowledge of GxP/GMP and electronic records considerations; willing to travel 80–100%.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
• Assess current processes, data flows, and system landscapes to close quality gaps.
• Translate priorities into functional designs, requirements and acceptance criteria.
• Develop designs for deviations, CAPA, change control, audits and inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and related systems.
• Oversee testing, deployment readiness, training, and handover for the workstream.

Skills

Life Sciences Quality

Translate quality problems into specs

eQMS/QMS platforms

LIMS/MES/MOM/ERP familiarity

Data-driven decision making

Workshop facilitation and client comms

Education

Bachelor's degree in life sciences / related field

Tools

LIMS

MES/MOM

ERP

eQMS/QMS platforms

Document management systems

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory and manufacturing operations. Focus on quality-system performance, data integrity and inspection readiness in regulated environments.

You will drive workstreams from assessment to design, implementation and stabilization, coordinating experts and ensuring measurable improvements while embracing AI and analytics.