Life Sciences Quality Transformation Manager

EY

Washington (District of Columbia)

Remote

USD 128,000 - 267,000

Full time

8 days ago

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Benefits offered by this job

Medical and dental coverage

Pension and 401(k) plans

Paid time off options

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation across QA/QC, laboratory and manufacturing operations in the United States. You will guide workstreams from assessment through solution design, implementation, testing, and stabilization, focusing on data integrity, inspection readiness, and quality-system performance.

You'll work with pharmaceutical, biotech and medical-device clients, coordinating quality teams, architects, data

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, or related field.
At least 7 years of relevant Life Sciences Manufacturing Quality experience.
Experience leading a client-facing quality/data/tech workstream through design and deployment.
Experience in regulated pharma/biotech/medical-device environments.
Knowledge of GxP/GMP and electronic-records-and-signatures considerations.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear deliverables.
Assess current-state quality processes, data flows, and site constraints via workshops and data analysis.
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 and document-management systems.
Define data mappings, master-data needs, and data-quality controls for reporting and AI use cases.
Help deliver quality analytics and AI use cases by assessing data readiness and governance.
Work with validation teams to reflect GxP/Electronic records requirements in deliverables.
Oversee configuration, testing, deployment readiness, training and handover.
Facilitate sessions across quality, manufacturing, IT, data and vendors; manage dependencies.
Manage scope, schedule, resources, quality, and risks; contribute to estimates and proposals.
Coach junior team members and capture reusable requirements.