Quality Systems & Compliance Manager: Audits & Training

Regulatory Jobs; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Health insurance

401(k)

Job summary

AbbVie is seeking a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and inspection readiness. You will drive the quality systems across the site, support training programs, and lead supplier quality initiatives in partnership with Global Supplier Quality.

The role requires a Bachelor’s in health science or quality, 5+ years pharma experience with 1-3 years in QA/QC management, and proven ability to ensure regulatory compliance

Qualifications

• Bachelor’s degree in health science or quality; advanced degree preferred.
• Minimum 5 years pharma experience; 1-3 years should be quality and management experience.
• Experience managing supplier quality, delivering training, ensuring compliance with external regulatory requirements, and adhering to corporate quality systems.

Responsibilities

• Oversee and manage regulatory, quality, and corporate audits and track action items to completion.
• Ensure site compliance with regulatory and current GMP requirements.
• Ensure site implements and sustains AbbVie quality systems as per policies and docs.
• Maintain inspection readiness through evaluation of compliance status of site and personnel.
• Develop and maintain an inspection management plan and SME training roadmap with refresher trainings.
• Perform GEMBA walks to identify and address quality and compliance issues.
• Author, implement, and maintain the BLI Inspection Readiness Plan.
• Ensure site meets training and compliance metrics; improve training program and guide resources.
• Manage site supplier quality program with Global Supplier Quality to ensure policy compliance.

Skills

Quality systems management

Supplier quality management

Compliance training

Regulatory compliance

Audit management

Education

Bachelor’s degree in health science or quality

Advanced degree preferred

Job description

AbbVie is seeking a Quality Systems and Compliance Manager to oversee regulatory, quality, and corporate audits, ensuring GMP compliance and inspection readiness. You will drive the quality systems across the site, support training programs, and lead supplier quality initiatives in partnership with Global Supplier Quality.

The role requires a Bachelor’s in health science or quality, 5+ years pharma experience with 1-3 years in QA/QC management, and proven ability to ensure regulatory compliance