Strategic Quality Systems Leader for Regulatory Excellence

AbbVie; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie is seeking a Manager of Quality Systems to support QA for pharmaceutical products, biologics, cosmetics and devices. You will translate strategy into tactical objectives and lead quality initiatives across multiple functions to ensure compliance with corporate policies and regulatory requirements.

The role involves supplier qualification, risk management, and governance across ASL processes, with exposure to regulatory audits and continuous improvement activities.

Qualifications

• Bachelor's degree in a technical/ scientific field is preferred.
• 8+ years in quality assurance or related experience.
• Experience leading cross-functional teams.
• Knowledge of QA systems and GMP compliance.
• Familiarity with drug, biologics, cosmetics, device regulations.
• Strong oral and written communication.
• Able to manage medium to large projects.

Responsibilities

• Ensure proper integration and support of quality regulations across drug, biologics, cosmetcis, device and/or combination products.
• Lead project teams in planning, review and approval of quality documentation.
• Implement and maintain the effectiveness of the quality system including regulatory audits.
• Design quality systems, procedures and processes within cross functional teams for compliance and efficiency.
• Coordinate quality system elements, training, and continuous improvement across functions and plants.
• Support new product introductions for pharmaceutical products and devices.
• Interact with internal and external partners to develop best practices in our quality systems.
• Perform assessments to identify gaps and mitigate improvements within the quality system.

Skills

Quality systems

Regulatory compliance

Leadership

Cross-functional teams

GMP compliance

Quality documentation

Communication skills

Education

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area

Job description

AbbVie is seeking a Manager of Quality Systems to support QA for pharmaceutical products, biologics, cosmetics and devices. You will translate strategy into tactical objectives and lead quality initiatives across multiple functions to ensure compliance with corporate policies and regulatory requirements.

The role involves supplier qualification, risk management, and governance across ASL processes, with exposure to regulatory audits and continuous improvement activities.