Senior Manager, Quality Systems
AbbVie · Irvine, CA · 4 wk ago
OTHRFull-time
About the role
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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 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.
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,