Life Sciences Quality Transformation Manager

EY; Tucson (AZ); Remoto; USD 128.000 - 235.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical and dental coverage

Pension and 401(k)

Paid time off

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams that strengthen quality systems and inspection readiness across manufacturing and laboratory operations. The role blends practical quality expertise with digital QMS, data, AI, and delivery skills to turn quality needs into implementable solutions.

You will guide workstreams from assessment through design, implementation, testing, adoption, and stabilization, focusing

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, or related field.
• Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation.
• Experience in pharmaceutical, biotechnology, medical-device, or comparably regulated manufacturing environments.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and deliverables.
• Assess current-state quality processes, data flows, and site constraints through workshops and data analysis.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for deviations, CAPA, change control, audits and inspection readiness.
• Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and laboratory systems with architects and cybersecurity specialists.
• Define data mappings, master-data needs, interface specifications, and data-quality controls for reporting and AI use cases.
• Help deliver quality analytics and AI use cases with data readiness and governance considerations.
• Work with validation teams to reflect GxP/GMP and 21 CFR 11 considerations in workstream deliverables.
• Oversee testing, deployment readiness, training, cutover support, and handover for the workstream.
• Facilitate working sessions across multiple teams and manage dependencies and risks.
• Manage workstream scope, schedule, resources, and budgets; contribute to proposals and follow-on opportunities.
• Coach junior team members and capture reusable requirements and delivery lessons.

Conoscenze

Quality management

Data analytics

Stakeholder engagement

Workshop facilitation

Formazione

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

Strumenti

eQMS/QMS platforms

LIMS

APIs

Quality analytics tools

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams that strengthen quality systems and inspection readiness across manufacturing and laboratory operations. The role blends practical quality expertise with digital QMS, data, AI, and delivery skills to turn quality needs into implementable solutions.

You will guide workstreams from assessment through design, implementation, testing, adoption, and stabilization, focusing