Client-Facing Life Sciences Quality Transformation Manager

EY; McLean (VA); Remote; USD 140,000 - 230,000; Full time

Job summary

EY is seeking a Client-facing Manager in Life Sciences Manufacturing Quality to lead technology-enabled workstreams that strengthen quality systems, compliance, and inspection readiness across manufacturing and laboratory operations. The role blends practical quality expertise with digital QMS, data, AI, and delivery skills.

You will collaborate with pharmaceutical, biotechnology, and medical-device clients to deliver end-to-end solutions, driving outcomes from assessment through design,

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
• At least 7 years of relevant Life Sciences Manufacturing Quality experience.
• Experience leading a client-facing quality/tech workstream through design and deployment phases.
• Experience in regulated manufacturing (pharma/biotech/medical devices).
• Ability to translate quality needs into process, data and testing deliverables.
• Knowledge of GxP/GMP, electronic records and signatures.
• Ability to travel as needed (80–100%).

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear plans and deliverables.
• Assess current-state quality processes, data flows, and gaps through workshops and analysis.
• Translate quality needs into functional designs, acceptance criteria, and measurable improvements.
• Develop designs for deviations, CAPA, change control, and inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and document-management systems.
• Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
• Support quality analytics and AI use cases with data readiness and governance.

Skills

Quality management

Digital QMS

Data analysis

Stakeholder coordination

Workshop facilitation

GxP/GMP knowledge

Travel readiness

Education

Bachelor’s degree in life sciences/engineering/quality/supply chain

Tools

eQMS/QMS

LIMS

MES/MOM

ERP

Document-management systems

Job description

EY is seeking a Client-facing Manager in Life Sciences Manufacturing Quality to lead technology-enabled workstreams that strengthen quality systems, compliance, and inspection readiness across manufacturing and laboratory operations. The role blends practical quality expertise with digital QMS, data, AI, and delivery skills.

You will collaborate with pharmaceutical, biotechnology, and medical-device clients to deliver end-to-end solutions, driving outcomes from assessment through design,