Life Sciences Quality Transformation Manager

EY

San Diego (CA)

On-site

USD 128,000 - 267,000

Full time

9 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 workstreams across QA/QC, data integrity, and inspection readiness in regulated manufacturing and lab operations.

You will guide design, implementation, testing, adoption, and stabilization of quality solutions, coordinating multidisciplinary teams and driving measurable improvements in quality performance and compliance.

Qualifications

Bachelor’s degree in life sciences, engineering, quality, supply chain, information systems, or related field.
At least 7 years of relevant Life Sciences Manufacturing Quality experience.
Experience leading a client-facing quality/ digital workstream through design and deployment.
Experience in regulated manufacturing environments (pharma/biotech/medical devices).
Practical understanding of GxP/GMP and electronic records considerations.
Ability to travel as needed (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, data flows, and site constraints.
Translate priorities into process designs, requirements, and acceptance criteria.
Develop designs for deviations, CAPA, change control, audits, supplier quality, and batch disposition.
Coordinate cross-system integration across eQMS/QMS, LIMS, MES/MOM, ERP and lab informatics.
Define data mappings and quality reporting data requirements.
Support AI use cases in quality analytics and decision support.
Ensure compliance with audit trails, traceability, and electronic records.
Oversee testing, deployment readiness, training, and handover for the workstream.
Facilitate sessions across multiple domains and manage risks and scope.