AI-Driven Life Sciences Quality Manager

EY; Cincinnati (OH); On-site; USD 128,000 - 257,000; Full time

Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off options

Job summary

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

You will coordinate cross-functional teams, translate quality needs into actionable requirements, and manage workstreams through design, deployment, and stabilization with senior guidance.

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or a related discipline.
• At least 7 years of relevant Life Sciences Manufacturing Quality, QA/QC, quality technology, or related experience.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one deployment phase.
• Experience in pharmaceutical/biotech/medical-device regulated environments.
• Ability to translate quality needs into process, data, and testing deliverables with cross-functional teams.
• Knowledge of GxP/GMP, electronic records and signatures, and change-control considerations.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits, and quality risk management.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and document-management systems.
• Define data mappings and data-quality controls for reporting, analytics, and AI use cases.
• Support AI-enabled quality investigations, anomaly detection, and decision-support while ensuring governance.
• Work with validation teams to reflect GxP and electronic-records requirements in deliverables.
• Oversee configuration, testing, deployment readiness, training, and handover for the workstream.
• Facilitate cross-team sessions across quality, manufacturing, IT, and vendors; manage scope and risks.
• Coach junior staff and capture reusable requirements and delivery lessons.

Skills

Client-facing leadership

Quality domain acumen

Digital quality workflows

Data analytics mindset

Workshop facilitation

Delivery risk management

Education

Bachelor’s degree in life sciences, engineering, quality, or related

Tools

eQMS/QMS platforms

LIMS

MES/MOM

ERP systems

APIs and lab informatics connectivity

Cybersecurity collaboration

Job description

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

You will coordinate cross-functional teams, translate quality needs into actionable requirements, and manage workstreams through design, deployment, and stabilization with senior guidance.