Associate Director Quality, Microbial Contamination Control

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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