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, 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.