Life Sciences Quality Transformation Lead

EY

San Francisco (CA)

On-site

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

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager to lead technology-enabled transformation, strengthening quality systems, compliance, audit readiness, and product quality across manufacturing and laboratory operations. You will drive delivery from assessment to stabilization, focusing on data integrity and inspection readiness.

This techno-functional role requires coordinating quality, QA/QC, IT, and vendor teams, translating needs into actionable requirements, and

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, business or related discipline.
At least 7 years of experience in Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data and AI, or related field.
Experience leading client-facing quality, digital, data, or technology workstreams through design and at least one implementation.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation.
Assess current-state quality processes and data flows to identify improvements.
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 lab systems.
Define data mappings and data-quality controls for reporting and AI use cases.
Deliver quality analytics and AI use cases with governance and controls.
Ensure compliance with GxP/GMP, electronic records, and validation requirements.
Oversee testing, deployment readiness, training, and handover for your workstream.
Facilitate cross-functional sessions to accelerate decisions and risk management.
Manage scope, schedule, resources, and risks; contribute to proposals.