Senior Life Sciences Quality Transformation Manager

EY; Toledo (OH); 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 options

Job summary

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled transformations across pharmaceutical, biotech, and medical-device manufacturing environments. You will guide quality, QA/QC, laboratory, and IT teams, designing and delivering end-to-end workstreams that improve data integrity, inspection readiness, and quality-system performance.

The role emphasizes a techno-functional mix, stakeholder management, and driving value realization while aligning with GxP/GMP

Responsibilities

• Lead client-facing Life Sciences Manufacturing Quality transformation workstreams with clear ownership of plans, deliverables, risks, decisions, and outcomes.
• Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps, and site constraints through workshops and data analysis.
• Translate quality and lab needs into actionable requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations/nonconformances, investigations, CAPA, change control, complaints, audits and inspection readiness, supplier quality, batch disposition and review by exception, and quality risk management.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and laboratory-instrument systems with architects and cybersecurity specialists.
• Define and review data mappings, master-data needs, interface specifications, and data-quality controls for quality reporting, analytics, and AI use cases.
• Help deliver quality analytics and AI use cases, assessing data readiness, workflow fit, evaluation criteria, and governance.
• Work with validation teams to reflect GxP/GMP, data-integrity, electronic-records-and-signatures, and audit-trail requirements in workstream deliverables.
• Oversee configuration activities and lead testing, defect resolution, deployment readiness, training, cutover support, and handover.
• Facilitate working sessions across quality, QA/QC, manufacturing, laboratory, IT, data, and technology vendors; manage dependencies.
• Manage workstream scope, schedule, resources, quality, and risks; provide status updates and contribute to proposals.
• Coach junior team members and capture reusable requirements and delivery lessons.

Job description

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled transformations across pharmaceutical, biotech, and medical-device manufacturing environments. You will guide quality, QA/QC, laboratory, and IT teams, designing and delivering end-to-end workstreams that improve data integrity, inspection readiness, and quality-system performance.

The role emphasizes a techno-functional mix, stakeholder management, and driving value realization while aligning with GxP/GMP