Life Sciences Quality Transformation Manager

EY

San Jose (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) plans

Paid time off options

Job summary

EY is seeking a Client-facing Life Sciences Manufacturing Quality Manager who leads technology-enabled transformation workstreams to strengthen quality systems, compliance, and inspection readiness across manufacturing and laboratory operations. You will drive end-to-end delivery from assessment to adoption, focusing on data integrity, AI use cases, and measurable quality improvements.

This techno-functional role requires coordinating with QA, quality systems, IT, data, and vendor teams,

Qualifications

Bachelor’s degree or higher in life sciences, engineering, quality, supply chain, information systems, business, or related discipline.
7+ years of relevant Life Sciences Manufacturing Quality, QA/QC, quality technology, industrial data & AI, technology consulting, or related field.
Experience leading a client-facing quality, digital, data, or technology workstream through design and at least one implementation or deployment phase.
Experience in pharmaceutical/biotech/medical-device or comparably regulated manufacturing environments.
Ability to translate quality-domain needs into process, functional, data, integration, or testing deliverables and coordinate business and technical contributors.
Knowledge of GxP/GMP documentation, change-control, data-integrity, and e-signature considerations for digital quality solutions.

Responsibilities

Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with ownership of plans, deliverables, risks, decisions, and outcomes.
Assess current-state quality processes, user needs, data flows, performance gaps, and site constraints through workshops and data analysis.
Translate priorities into process designs, requirements, acceptance criteria, and measurable improvements.
Develop functional designs for deviations, CAPA, change control, audits and inspection readiness, supplier quality, batch disposition and review by exception, and risk management.
Coordinate integration requirements across eQMS/QMS, LIMS, MES/MOM, ERP and laboratory informatics systems with architects, data engineers and cybersecurity teams.
Define data mappings, master-data needs, interface specifications, and data-quality controls for quality reporting and AI use cases.
Support AI/analytics use cases with data readiness assessment, governance, and human-in-the-loop controls.
Work with QA/validation teams to reflect GxP/electronic records requirements in workstream deliverables.
Oversee configuration, testing, deployment readiness, training, cutover, hypercare, and handover.