Life Sciences Quality Transformation Manager

EY; Indianapolis (IN); Remote; USD 128,000 - 235,000; 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 Manager in Life Sciences Manufacturing Quality to lead technology-enabled transformation across quality, QA/QC, laboratory and manufacturing operations. You will drive workstreams from assessment through design, implementation and stabilization with a focus on data integrity and inspection readiness.

This techno-functional role requires coordinating quality, IT, and vendor teams in regulated environments, delivering measurable improvements and ensuring audit-ready configurations.

Qualifications

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

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
• Assess current-state quality processes, data flows, and site constraints.
• Translate priorities into functional designs, acceptance criteria, and measurable improvements.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and lab systems.
• Define data mappings, master-data needs, and quality reporting requirements.
• Oversee testing, deployment readiness, training, and handover for your workstream.
• Facilitate sessions across quality, lab, manufacturing, IT, and vendors.

Skills

Quality-domain storytelling

Cross-functional leadership

Workshop facilitation

Quality analytics

Data integration thinking

Delivery risk management

Education

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business

At least 7 years of relevant Life Sciences Manufacturing Quality experience

Tools

eQMS/QMS platforms

LIMS

MES/MOM

ERP

document-management

Job description

EY is seeking a Manager in Life Sciences Manufacturing Quality to lead technology-enabled transformation across quality, QA/QC, laboratory and manufacturing operations. You will drive workstreams from assessment through design, implementation and stabilization with a focus on data integrity and inspection readiness.

This techno-functional role requires coordinating quality, IT, and vendor teams in regulated environments, delivering measurable improvements and ensuring audit-ready configurations.