AI’s Impact on Quality Management in Pharma Manufacturing

The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful tool to help quality professionals synthesize information more efficiently, improve consistency across investigations, and support more informed decision-making. In this episode of Off Script, we spoke with Charlie Lickfold, Chief Technology Officer at Catalent, about how the company is deploying AI to modernize pharmaceutical quality management. Lickfold explains why advanced modalities like cell and gene therapies are driving demand for AI-enabled quality systems, how Catalent’s new QAI platform is assisting in quality management, and why human oversight remains essential in regulated quality operations. He also discusses evolving regulatory expectations, AI governance, and organizational strategies that can support successful enterprise AI deployment.