Associate Director, Quality Control, Carlow - Hybrid

Are you passionate about delivering life-changing medication to patients around the world? At our state-of-the-art Carlow site, you will be at the forefront of ensuring the highest standards of microbiological quality and compliance. We are seeking a dynamic and committed Associate Director, Quality Control to join our expanding team. 

Your Core Responsibilities 

• Serve as the Subject Matter Expert (SME) for all plant microbiological concerns, providing guidance and support to various departments. 
• Share expertise on microbiological procedures and best practices to ensure compliance and operational efficiency. 
• Participate in microbial-related investigations, contributing to root cause analysis (RCA) teams to identify issues and develop preventive actions. 
• Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments. 
• Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies. 
• Support the inspection readiness program, ensuring microbiological practices meet regulatory and internal compliance standards. 

Who You Are 

You are ready if you have: 

• Bachelor’s degree in microbiology or a relevant discipline. 
• Relevant experience at this level in plant microbiology or a related area. 
• Strong understanding of microbiological principles and practices, ideally in a sterile plant environment. 
• Expertise in Eudralex Annex 1 requirements. 
• Experience in technical appraisal, document review, and audits. 
• Excellent analytical and problem-solving skills. 
• Strong written and verbal communication abilities. 
• Proven experience in root cause analysis and risk management.