Life Sciences Quality Transformation Manager

EY

Milwaukee (WI)

Remoto

USD 128.000 - 257.000

Tempo pieno

8 giorni fa

Una candidatura completa in un minuto

Curriculum e lettera di presentazione personalizzati, pronti da inviare.

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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 to lead technology-enabled transformations across QA/QC, quality systems, and data analytics in regulated manufacturing and laboratory operations. The role blends practical quality expertise with digital QMS, AI, and delivery skills to translate quality needs into practical solutions.

You will steer workstreams from assessment through design, implementation, testing, adoption, and stabilization, focusing on data integrity

Competenze

Bachelor’s degree in life sciences, engineering, quality, information systems, 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.
Experience translating quality-domain needs into process, data, or testing deliverables and coordinating contributors.
Knowledge of GxP/GMP and related documentation, change-control, data integrity, and e-records considerations.
Willingness to travel as needed (80-100%).

Mansioni

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, system landscapes, data flows, and site constraints.
Translate priorities into functional designs, acceptance criteria, and measurable improvements.
Develop designs for deviations, CAPA, change control, audits, supplier quality, and batch disposition.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP, and lab systems with architects and cybersecurity teams.
Define data mappings and data-quality controls for reporting, analytics, and AI use cases.
Deliver quality analytics and AI use cases by assessing data readiness and governance.
Ensure regulatory requirements (GxP/GMP, 21 CFR Part 11) are reflected in deliverables.
Oversee testing, defect resolution, deployment readiness, and training for the workstream.
Facilitate cross-functional sessions across quality, manufacturing, IT, data, and vendors.
Manage scope, schedule, resources, quality, and risks; contribute to estimates and proposals.
Coach junior team members and capture reusable requirements.