Quality Systems & Compliance Lead - GMP & Audit Readiness

AbbVie; Irvine (CA); On-site; USD 110,000 - 180,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a Quality Systems and Compliance Manager to oversee regulatory, quality and corporate audits and ensure GMP compliance across the site.

You will lead inspection readiness, develop an inspection plan, mentor SME training, and drive improvements in supplier quality in partnership with Global Supplier Quality. A strong pharma background and 5+ years experience are required.

Qualifications

• Bachelor's degree in health science or quality background.
• Advanced degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience.

Responsibilities

• Oversee and manage 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 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.

Skills

Quality management

Regulatory compliance

Auditing

GMP knowledge

Training & coaching

Education

Bachelor’s degree in health science or quality

Advanced degree preferred

Job description

AbbVie in Irvine, CA is seeking a Quality Systems and Compliance Manager to oversee regulatory, quality and corporate audits and ensure GMP compliance across the site.

You will lead inspection readiness, develop an inspection plan, mentor SME training, and drive improvements in supplier quality in partnership with Global Supplier Quality. A strong pharma background and 5+ years experience are required.