Quality Systems & Compliance Manager: GMP, Audits & Training

Allergan; Irvine, Northern (CA, KY); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie seeks a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and sustained quality systems. The role requires driving inspection readiness and improving training programs to uphold AbbVie's quality standards across the site.

The successful candidate will manage supplier quality in partnership with Global Supplier Quality, develop inspection plans, and lead continuous improvements in training and compliance metrics.

Qualifications

• Bachelor’s Degree in related 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 all regulatory, quality, and corporate audits and track action items.
• Ensure site complies with regulatory and current GMP requirements.
• Ensure site implements and sustains AbbVie quality systems and policies.
• Maintain inspection readiness through ongoing evaluation of compliance status.
• Develop and maintain an inspection management plan and SME training programs.
• Perform GEMBA walks to identify and address quality and compliance issues.

Skills

Quality systems management

Supplier quality

Compliance

Inspection readiness

Site training

Education

Bachelor’s Degree in health science or quality

Advanced degree preferred

Job description

AbbVie seeks a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and sustained quality systems. The role requires driving inspection readiness and improving training programs to uphold AbbVie's quality standards across the site.

The successful candidate will manage supplier quality in partnership with Global Supplier Quality, develop inspection plans, and lead continuous improvements in training and compliance metrics.