Senior Manager, Quality Systems

AbbVie • Irvine, CA

1d

About The Position

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. The Quality Systems and Compliance Manager will have 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

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.

Benefits

• paid time off (vacation, holidays, sick)
• medical/dental/vision insurance
• 401(k)
• long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior