Life Sciences Quality Transformation Manager

EY; Miami (FL); Remote; 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 Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems, data, AI, and regulatory readiness in pharmaceutical manufacturing and laboratory operations.

You will manage workstreams from assessment through implementation, coordinating quality, QA/QC, lab, manufacturing, IT, and external partners while focusing on data integrity and inspection readiness.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related.
• At least 7 years of Life Sciences Manufacturing Quality or related experience.
• Experience leading a client-facing quality/technology workstream through design and deployment.
• Experience in regulated manufacturing environments (pharma/biotech/medical devices).
• Ability to translate quality needs into process and data requirements with deliverables.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans and outcomes.
• Assess current-state quality processes, data, and systems to drive improvements.
• Translate priorities into designs, requirements, and acceptance criteria.
• Develop functional designs for deviations, CAPA, change control, audits, and QA/QC processes.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and related systems.
• Define data mappings, master data needs, and data-quality controls for reporting and AI use cases.
• Support AI use cases with data readiness and governance considerations.
• Ensure GxP/GMP, electronic records/signatures, and validation considerations are reflected in deliverables.
• Oversee testing, deployment readiness, training, and handover for the workstream.
• Facilitate collaboration across quality, manufacturing, laboratory, IT, and vendor teams.

Skills

Quality management

Client-facing

Delivery leadership

Data analytics

GxP/GMP experience

Education

Bachelor's degree (life sciences or related)

Tools

eQMS/QMS platforms

LIMS

MES/MOM

ERP

Job description

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across quality systems, data, AI, and regulatory readiness in pharmaceutical manufacturing and laboratory operations.

You will manage workstreams from assessment through implementation, coordinating quality, QA/QC, lab, manufacturing, IT, and external partners while focusing on data integrity and inspection readiness.