Associate Director Quality - Microbial Contamination Control

Job Description

Reporting to the Director of Sterility Assurance and Contamination Control, the Associate Director of Quality, Microbial Contamination Control is a pivotal role in providing quality oversight and leading improvement initiatives for sterility assurance and contamination control across AbbVie’s internal sites and external manufacturing network. The role ensures AbbVie processes and procedures meet current and emerging regulatory requirements and industry best practice for sterile drug and biological products manufactured by aseptic processing or terminal sterilization.  This includes providing technical and quality assurance expertise, driving education and training, and identifying and mitigating potential risks to product quality across aseptic processing and sterile manufacturing operations.

• Develop and implement comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines
• Serves as a knowledgeable technical and quality resource for the AbbVie network with regards to contamination control and associated strategies.
• Lead contamination control initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments
• Provide Quality and Compliance guidance to the global Sterile and Bulk Drug substance sites supporting inspection readiness and sterility assurance
• Provide AbbVie sites technical guidance for aseptic process simulation programs, air flow visualization studies, disinfection validation programs, and environmental monitoring programs
• Lead Contamination Control assessments for aseptic processing steps identifying opportunities to improve site level contamination control strategies
• Supports Site regulatory inspections and self-inspection programs
• Provide aseptic subject matter expertise to external manufacturing quality assurance and act as subject matter expert for external manufacturing auditing program
• Provide specialist technical and compliance guidance to manufacturing site event investigations
• Provide aseptic development and mentoring to sites and functional groups
• Assess the AbbVie Quality System for revision in compliance with applicable regulatory requirements and alignment with regulatory expectations
• Member of AbbVie’s Centers of Excellence for Contamination Control and Microbiology laboratories
• Provide quality and compliance guidance to the sites for the development of environmental monitoring programs and trending processes to ensure the capturing of and assessment of critical data pertaining to microbial control at a level commensurate with the product and process risk.

Qualifications

• Bachelor/Master Degree in Microbiology and/or suitable science qualification
• Minimum 7-10 years relevant experience and aseptic process knowledge within Pharmaceutical and/or Biopharmaceutical industry
• Knowledge of Pharmaceutical Regulatory Requirements and expectations including Code of Federal Regulations, EU GMPs, EMA /FDA Guidelines, Pharmacopeia, PIC/S
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve
• Proven history of implementing innovative approaches
• Demonstrated ability to effectively interface with multiple regulatory agencies
• Ability to evaluate quality, production and support areas for compliance with Good Manufacturing Practices (GMP).
• Excellent Communication skills both verbally and written

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html