Client-Facing Life Sciences Quality Manager

EY; Phoenix (AZ); Remoto; USD 150.000 - 260.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k) plans

Paid time off

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to transform quality systems using digital QMS, data, and AI in regulated environments. You will lead end-to-end workstreams across QA/QC, manufacturing, and laboratory operations, ensuring inspection readiness and CAPA effectiveness.

The role focuses on turning quality needs into actionable requirements, coordinating specialists, and delivering measurable improvements while traveling as needed in a high-engagement

Competenze

• Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
• At least 7 years of relevant experience in Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data and AI, technology consulting, or related field.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation or deployment phase.
• Experience in pharmaceutical/biotech/medical-device or regulated manufacturing environments.
• Translation of quality-domain needs into process, functional, data, integration, or testing deliverables and coordinating business and technical contributors.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans, deliverables, risks and outcomes.
• Assess current-state quality processes, user needs, system landscapes, data flows, performance gaps and site constraints.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, investigations, CAPA, change control, audits/inspection readiness, supplier quality, batch disposition and review by exception.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and document-management systems; work with architects, data engineers, and cybersecurity specialists.
• Define and review data mappings, master-data needs, interface specs, and data-quality controls for reporting, analytics and AI use cases.
• Help deliver quality analytics and AI use cases by assessing data readiness and governance.
• Work with quality and validation teams to reflect GxP/GMP and electronic-records-and-signatures considerations in workstream deliverables.
• Oversee configuration activities, testing, deployment readiness, training, cutover support, hypercare, and handover.
• Facilitate working sessions across quality, QA/QC, manufacturing, lab, IT, and vendor teams; manage dependencies for the broader program.
• Manage scope, schedule, resources, quality and risks; contribute to estimates, proposals, and follow-on opportunities.
• Coach junior team members and capture reusable requirements and delivery lessons.

Conoscenze

Life Sciences Manufacturing Quality

Quality-domain problem solving

eQMS/QMS platforms

LIMS integration

Data analytics awareness

Formazione

Bachelor’s degree in life sciences or related field

Strumenti

LIMS

eQMS/QMS platforms

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to transform quality systems using digital QMS, data, and AI in regulated environments. You will lead end-to-end workstreams across QA/QC, manufacturing, and laboratory operations, ensuring inspection readiness and CAPA effectiveness.

The role focuses on turning quality needs into actionable requirements, coordinating specialists, and delivering measurable improvements while traveling as needed in a high-engagement