Quality Systems Leader – GMP & Regulatory Compliance

Regulatory Jobs; Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie's Chicago-based team seeks a Manager of Quality Systems to lead the quality program governance across drug, biologics, cosmetics, and device areas. You will design and maintain quality systems, oversee supplier qualification, change control, and audits.

The role requires 8+ years in QA, a technical degree, and proven leadership of cross-functional teams. You will collaborate with R&D, Manufacturing, Regulatory, and Supply Chain to ensure compliance and continuous improvement.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 8+ years’ experience in quality assurance, quality oversight or relevant experience.
• Leadership of technical professionals and in leading cross-functional teams.
• Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products.
• Strong oral and written communication skills; ability to work with management and cross-functional teams.

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.
• May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Manage and 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. Support design changes to existing medical devices and/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

QA Leadership

Regulatory Knowledge

Cross-functional Leadership

Quality Assurance

Project Management

Strong Communication

Education

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

Job description

AbbVie's Chicago-based team seeks a Manager of Quality Systems to lead the quality program governance across drug, biologics, cosmetics, and device areas. You will design and maintain quality systems, oversee supplier qualification, change control, and audits.

The role requires 8+ years in QA, a technical degree, and proven leadership of cross-functional teams. You will collaborate with R&D, Manufacturing, Regulatory, and Supply Chain to ensure compliance and continuous improvement.