Life Sciences Quality Transformation Manager

EY

San Mateo (CA)

Remote

USD 161,000 - 267,000

Full time

8 days ago

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Benefits offered by this job

Medical and dental coverage

Pension and 401(k)

Paid time off options

Job summary

EY seeks a Client-facing Manager in Life Sciences Manufacturing Quality to lead techno-functional workstreams that strengthen quality systems, audit readiness, and product quality across manufacturing and laboratory operations.

You will coordinate with QA/QC, manufacturing, IT, and data teams to translate quality needs into actionable requirements, designs, and measurable improvements, including AI-enabled analytics and data governance.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business, or related field.
At least 7 years of relevant Life Sciences Manufacturing Quality experience.
Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one deployment.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
Assess current-state processes, data flows, gaps, and constraints through workshops and data analysis.
Translate priorities into designs, requirements, acceptance criteria, and measurable improvements.
Define functional designs for deviations, CAPA, change control, audits, and inspection readiness.
Coordinate integration across eQMS/QMS, LIMS, MES/MOM, ERP and lab systems; govern data quality.