Associate Director Quality, Microbial Contamination Control

📋 Description

• Develop and implement comprehensive sterility assurance frameworks, including contamination control
• Serve as a knowledgeable technical and quality resource for the AbbVie network with regards to
• Lead contamination control initiatives to continuously improve aseptic techniques, gowning
• Provide Quality and Compliance guidance to the global Sterile and Bulk Drug substance sites
• Provide AbbVie sites technical guidance for aseptic process simulation programs, air flow
• Lead Contamination Control assessments for aseptic processing steps identifying opportunities to

🎯 Requirements

• Bachelor or Master Degree in Microbiology and/or suitable science qualification
• Minimum 7-10 years relevant experience and aseptic process knowledge within Pharmaceutical and/or
• Knowledge of Pharmaceutical Regulatory Requirements and expectations including Code of Federal
• Ability to anticipate problems, identify and investigate them, and make recommendations to help
• Proven history of implementing innovative approaches
• Demonstrated ability to effectively interface with multiple regulatory agencies