Senior Manager, Quality Systems

AbbVie•Irvine, CA

8h•$124,500 - $236,500•Onsite

About The Position

Quality Systems and Compliance Manager with knowledge of quality systems management, supplier quality, compliance, inspection readiness, and site training, providing oversight to ensure consistently high levels of quality performance.

Requirements

Bachelor’s Degree with related health science or quality background.
Minimum 5 years pharma experience; 1-3 years should be quality and management experience
Experience managing supplier quality, delivering training, ensuring compliance with external regulatory requirements, and adhering to corporate quality systems

Nice To Haves

Advance degree preferred.

Responsibilities

Oversee and manage all aspects of regulatory, quality, and corporate audits, and track resulting action items to ensure timely completion.
Ensure site complies with all applicable regulatory and current Good Manufacturing Practice (GMP) requirements.
Ensure site implements and sustains all aspects of the quality systems defined in AbbVie policies and operational documents.
Maintain inspection readiness through ongoing evaluation and assessment of the compliance status site and personnel.
Develop and maintain an inspection management plan and roadmap, including room setups, area-specific subject matter expert (SME) assignments, SME training, and periodic refresher training for audits.
Perform periodic GEMBA walks across all areas to identify and address quality and compliance issues.
Author, implement, and maintain the BLI Inspection Readiness Plan.
Ensure site meets and sustains all training and compliance metrics; identify and implement improvements to the site training program, and train and guide resources in quality and training improvement techniques.
Manage the site supplier quality program in partnership with Global Supplier Quality to ensure compliance with applicable policies and procedures.