Life Sciences Quality & Digital Transformation Manager

EY; Irvine (CA); Remote; USD 128,000 - 267,000; Full time

Benefits offered by this job

Medical and dental

Pension and 401(k)

Paid time off

Job summary

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled transformation efforts for pharmaceutical, biotechnology, and medical-device clients. You will guide quality, QA/QC, and lab teams through design, implementation, testing, and stabilization, focusing on data integrity, inspection readiness, and continuous improvement.

You will collaborate with senior engagement leaders, define workstream deliverables, and drive regulatory-aligned quality solutions across

Qualifications

• Bachelor’s degree in life sciences, engineering, quality, or related field.
• 7+ years in Life Sciences Manufacturing Quality or related field.
• Experience leading a client-facing quality/tech workstream through design and deployment.
• Experience in regulated pharma/biotech/medical-device environments.
• Translating quality needs into process, data, and testing deliverables.
• Knowledge of GxP/GMP, 21 CFR Part 11 or equivalent.
• Willingness to travel 80-100% as required.

Responsibilities

• Lead client-facing workstreams in Life Sciences Manufacturing Quality transformation with clear ownership of plans and outcomes.
• Assess current-state quality processes, data, and systems through workshops and analysis.
• 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.
• Support AI use cases and quality analytics with data readiness and governance.
• Oversee validation, testing, deployment, training, and handover for your workstream.
• Facilitate cross-functional sessions and manage scope, schedule, resources, and risks.
• Mentor junior staff and capture reusable requirements and design patterns.

Skills

Quality management

Client-facing leadership

Regulatory compliance

Data analytics

Digital QMS

Education

Bachelor's degree

Tools

eQMS/QMS platforms

LIMS

ERP

QA analytics tools

Job description

EY is seeking a Manager in Supply Chain Manufacturing Quality to lead technology-enabled transformation efforts for pharmaceutical, biotechnology, and medical-device clients. You will guide quality, QA/QC, and lab teams through design, implementation, testing, and stabilization, focusing on data integrity, inspection readiness, and continuous improvement.

You will collaborate with senior engagement leaders, define workstream deliverables, and drive regulatory-aligned quality solutions across