Life Sciences Quality Transformation Lead

EY

Chicago (IL)

Remoto

USD 128.000 - 257.000

Tempo pieno

8 giorni fa

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Descrizione del lavoro

EY is seeking a Client-facing Manager in Life Sciences Manufacturing Quality to lead technology-enabled transformation workstreams across quality systems, data, AI, and delivery in regulated environments. You will collaborate with pharmaceutical, biotechnology, and medical-device teams to drive quality improvements and inspection readiness.

The role requires navigating eQMS/QMS, LIMS, MES/MOM, ERP landscapes, and coordinating with cross-functional teams.

Competenze

Bachelor’s degree in life sciences, engineering, quality, or related field.
At least 7 years in Life Sciences Manufacturing Quality or related field.
Experience leading client-facing quality or digital workstreams.
Experience in regulated manufacturing environments (pharma/biotech/medical devices).
Ability to travel 80-100%.
Authorized to work in the U.S. without sponsorship.

Mansioni

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes and data flows.
Translate priorities into process designs, requirements and acceptance criteria.
Develop functional designs for deviations, CAPA, change control, audits and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP.
Define data mappings and data-quality controls for reporting and AI use cases.
Help deliver QA analytics and AI use cases with governance and controls.
Oversee testing, deployment readiness, training and handover for your workstream.
Facilitate sessions across quality, manufacturing, IT, and vendors.
Manage scope, schedule, resources, quality, and risks; support proposals.
Coach junior team members and capture reusable assets.