Life Sciences Quality Delivery Manager

EY

Salt Lake City (UT)

On-site

USD 128,000 - 267,000

Full time

8 days ago

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Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory, and production. You will drive quality-system performance, data integrity, and inspection readiness in pharma/biotech contexts.

You will coordinate cross-functional teams, translate complex quality needs into actionable requirements, and manage workstreams through design, build, and deployment phases while navigating regulatory requirements and

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
At least 7 years of relevant Life Sciences Manufacturing Quality experience.
Experience leading client-facing quality/ digital/ data workstreams through design and deployment.
Experience in regulated manufacturing environments (pharma/biotech/medical devices).
Ability to translate quality needs into process, data, and testing deliverables.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
Assess current-state quality processes, data flows, and site constraints through workshops and analysis.
Translate quality priorities into designs, requirements, acceptance criteria, and measurable improvements.
Develop functional designs for deviations, investigations, CAPA, change control, audits, and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and informatics systems.
Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
Support AI use cases like anomaly detection and predictive quality with data readiness assessment.
Ensure compliance with GxP/GMP, electronic records, and validation requirements in deliverables.
Oversee testing, training, deployment readiness, and handover for the workstream.
Facilitate cross-functional sessions across quality, manufacturing, IT, and data teams.