Quality Senior Manager

Senior Manager of Quality at a large pharmaceutical manufacturing facility responsible for leading quality assurance, quality control, and regulatory compliance functions. The role involves managing a team of quality professionals, overseeing budgets, and ensuring products meet cGMP and FDA requirements across multiple production types.

Responsibilities

• Lead and supervise a team of quality professionals across incoming QA, manufacturing QA, validation, quality control, and regulatory compliance
• Make decision-making authority on quality and regulatory compliance matters for the site
• Manage annual operating budget for the quality function and ensure consistent manufacturing compliance with corporate and regulatory standards
• Provide regulatory and technical guidance to plant departments and act as subject matter expert across AbbVie sites
• Communicate quality initiatives and management review findings to executive leadership

Requirements

• Bachelor's degree in physical sciences, life sciences, pharmacy, or engineering; Master's or PhD preferred
• 8+ years experience in manufacturing, QA, QC, or R&D in pharmaceutical, biologics, device, or chemical industries
• 4+ years supervisory or technical leadership experience
• Certified Quality Engineer or formal training in quality engineering and statistics preferred
• Knowledge of cGMP, FDA, EU, and DEA regulatory requirements
• Proficiency with statistical quality systems, electronic document management, and laboratory information management
• Strong oral and written communication skills and people management abilities