Life Sciences Quality Transformation Manager

EY

Chantilly (VA)

On-site

USD 128,000 - 267,000

Full time

8 days ago

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Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled workstreams that strengthen quality systems, QA/QC, laboratory operations, and data-driven decision making.

You will coordinate cross-functional teams, translate quality needs into actionable requirements, and drive end-to-end delivery across design, testing, and deployment in regulated manufacturing environments.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, or related discipline.
At least 7 years of relevant experience in Life Sciences Manufacturing Quality, QA/QC, or related field.
Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one deployment phase.
Experience in regulated manufacturing environments (pharma/biotech/medical devices).
Translate quality needs into process, data, and testing deliverables; coordinate contributors.
Understanding of GxP/GMP, data integrity, electronic records and signatures.
Willingness to travel (80–100%).

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes, data flows, and site constraints.
Translate priorities into functional designs, acceptance criteria, and measurable improvements.
Develop designs for deviations, CAPA, change control, and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and related systems.
Define data mappings and data-quality controls for reporting and AI use cases.
Oversee testing, deployment readiness, training, and cutover support.
Coach junior team members and capture reusable design patterns.