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Senior Manager, Quality Systems

Irvine, CA, us💼 Full-time🗓 2026-09-21 → 2026-09-25

Core

Oversee regulatory, quality, and corporate audits; ensure site compliance with GMP and AbbVie quality systems; manage inspection readiness and supplier quality programs.

Role type

Senior Manager, Quality Systems

Builds

Quality systems, inspection readiness plans, supplier quality programs

Domain

Pharmaceutical manufacturing / Quality Assurance

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

Regulatory audit management, GMP compliance, Quality systems implementation, Inspection readiness planning, Supplier quality management, GEMBA walk facilitation, Training program development, Action item tracking

Preferred skills

Advanced degree in health science or quality, 1-3 years of quality management experience

Technologies

AbbVie policies and operational documents

Responsibilities

Oversee and manage regulatory, quality, and corporate audits; Ensure site compliance with GMP and regulatory requirements; Maintain inspection readiness through ongoing evaluation; Develop and maintain inspection management plans; Perform GEMBA walks to identify quality issues; Manage the site supplier quality program

Seniority

Senior, hands-on IC

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