Life Sciences Quality Transformation Manager

EY

New York (NY)

Remote

USD 154,000 - 257,000

Full time

8 days ago

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Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off

Job summary

EY is seeking a Manager in Life Sciences Manufacturing Quality to lead client-facing workstreams that strengthen quality systems, data integrity, and inspection readiness across manufacturing and lab operations. You will translate quality needs into actionable requirements and coordinate with quality, IT, and vendor teams to drive measurable improvements.

The role blends practical quality-domain expertise with digital QMS and AI use cases, supporting regulatory compliance and continuous

Qualifications

Bachelor’s degree in life sciences, engineering, quality, or related field.
7+ years in Life Sciences Manufacturing Quality or related areas.
Experience leading client-facing quality/tech workstreams through design and deployment.
Experience in regulated manufacturing (pharma/biotech/medical devices).
Knowledge of GxP/GMP, 21 CFR Part 11, data integrity.
Willingness to travel 80-100%.
Authorized to work in the U.S. without sponsorship.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes and data flows.
Translate priorities into processes, requirements, and acceptance criteria.
Develop designs for deviations, CAPA, change control, audits.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP.
Define data mappings and data-quality controls for reporting and AI.
Oversee testing, deployment readiness, training, and handover.
Facilitate cross-functional sessions across teams.
Manage scope, schedule, resources, and risks.
Coach junior team members.