Tech-Driven Life Sciences Quality Delivery Manager

EY; Minneapolis (MN); Remoto; USD 128.000 - 235.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Descrizione del lavoro

EY seeks a Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformation across pharmaceutical, biotech and medical-device manufacturing. You will guide workstreams from assessment through implementation, focusing on quality-system performance, data integrity, and inspection readiness.

The role blends practical quality know-how with digital QMS, data, AI, and delivery skills, coordinating with senior engagement leaders to deliver measurable improvements.

Competenze

• 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, digital, data, or technology workstream through design and at least one deployment phase.
• Experience working in a pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environment.
• Experience translating quality-domain needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.
• Practical understanding of GxP/GMP and the documentation, change-control, data-integrity, and electronic-records-and-signatures considerations relevant to digital quality solutions.
• Ability to travel as needed based on business and role requirements. Travel can range from 80-100%.
• Candidates must be legally authorized to work in the U.S. without the need for employer sponsorship, now and in the future

Mansioni

• Lead client-facing Life Sciences Manufacturing Quality workstreams with 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 priorities such as right-first-time execution, cycle-time reduction, deviation and nonconformance reduction, CAPA effectiveness, and inspection readiness into process designs, requirements, acceptance criteria, and measurable improvements.
• Define and review data mappings, batch and investigation context, master-data needs, interface specifications, and data-quality controls needed for quality reporting, analytics, and AI use cases.
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, document-management, and laboratory-instrument and informatics systems.
• Oversee configuration activities and lead functional testing, defect resolution, deployment readiness, training, cutover support, hypercare, and handover for your workstream.
• Facilitate working sessions across quality, QA/QC, manufacturing, laboratory, MS&T, supply chain, IT, data, and technology-vendor teams; expedite decisions and dependencies.
• Coach junior team members, review their work products, and capture reusable requirements, design patterns, and delivery lessons.

Conoscenze

Workshop facilitation

Problem solving

Client communication

Team coordination

Delivery-risk management

Formazione

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

Strumenti

LIMS

eQMS/QMS platforms

APIs

Descrizione del lavoro

EY seeks a Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformation across pharmaceutical, biotech and medical-device manufacturing. You will guide workstreams from assessment through implementation, focusing on quality-system performance, data integrity, and inspection readiness.

The role blends practical quality know-how with digital QMS, data, AI, and delivery skills, coordinating with senior engagement leaders to deliver measurable improvements.