Life Sciences Quality Transformation Manager

EY; Denver (CO); Remoto; USD 128.000 - 257.000; Tempo pieno

Vantaggi offerti da questo lavoro

Total Rewards package including health

Medical and dental coverage

Pension and 401(k) plans

Wide range of paid time off

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformations across manufacturing and laboratory operations. You will steer workstreams from assessment through design, implementation, testing, and stabilization with a focus on data integrity and inspection readiness.

The role combines practical quality-domain expertise with digital QMS, data and AI capabilities, coordinating cross-functional teams and ensuring compliance with

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 working in 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; travel can range from 80-100%.

Mansioni

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
• Assess current-state quality processes, user needs, system landscapes, data flows and gaps.
• Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
• Develop functional designs for quality capabilities (deviations, CAPA, change control, audits).
• Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP, and related systems.
• Define data mappings and data-quality controls for reporting, analytics, and AI use cases.
• Help deliver quality analytics and AI use cases with data readiness and governance.
• Work with validation teams to reflect GxP and electronic-records requirements in deliverables.
• Oversee configuration activities, testing, deployment readiness, training, and handover.
• Facilitate sessions across quality, manufacturing, lab, IT, and vendors to accelerate decisions.
• Manage scope, schedule, resources, and risk; contribute to estimates and proposals.
• Coach junior team members and capture reusable patterns.

Conoscenze

Quality management

Data analysis

Stakeholder management

Workshops facilitation

Quality systems

GxP/GMP

Formazione

Bachelor's degree in life sciences/engineering/quality

Strumenti

eQMS/QMS

LIMS

MES/MOM

ERP

Document management systems

Descrizione del lavoro

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled quality transformations across manufacturing and laboratory operations. You will steer workstreams from assessment through design, implementation, testing, and stabilization with a focus on data integrity and inspection readiness.

The role combines practical quality-domain expertise with digital QMS, data and AI capabilities, coordinating cross-functional teams and ensuring compliance with