Senior Quality Systems Manager, Pharma & Devices

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 110,000 - 209,000; Full time

Job summary

AbbVie is seeking a Manager of Quality Systems to lead quality assurance across drug, biologics, cosmetics, device, and combination products. The role ensures compliance with corporate policies, regulatory standards, and interfaces with R&D, Manufacturing, Supply Chain, and Regulatory Affairs.

The position requires 8+ years in QA, strong leadership, and expertise in GMP and QA systems. Responsibilities include maintaining quality systems, audits, and continuous improvement initiatives within a

Qualifications

• 8+ years of experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and cross-functional teams.
• Knowledge of QA systems and GMP compliance requirements including regulations.

Responsibilities

• Ensure proper integration and support of quality regulations: drug, biologics, cosmetic, device and/or combination products.
• Lead project teams in planning, preparation, review and approval of quality documentation.
• Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, cosmetic, device and/or combination products including compliance with Corporate policies, processes and procedures.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• Oversee the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
• Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
• Support new product introduction for pharmaceutical products, medical devices, or combination products.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Oversee the implementation and management of training and education programs for various aspects of quality assurance.

Skills

Leadership

Cross-functional

Quality systems

Regulatory knowledge

Auditing

Project management

Communication

Time management

Education

Bachelor’s degree in Chemistry/Pharmacy/Biology/Engineering

Job description

AbbVie is seeking a Manager of Quality Systems to lead quality assurance across drug, biologics, cosmetics, device, and combination products. The role ensures compliance with corporate policies, regulatory standards, and interfaces with R&D, Manufacturing, Supply Chain, and Regulatory Affairs.

The position requires 8+ years in QA, strong leadership, and expertise in GMP and QA systems. Responsibilities include maintaining quality systems, audits, and continuous improvement initiatives within a