Episode Thirteen: Auditing AI: Quality, Compliance & the Role of GenAI in Pharma

Join us for the next episode of AI Uncovered featuring Oeystein Kjoersvik to AI Uncovered. Oeystein leads the Generative AI program within the Quality Assurance team at Merck, where he focuses on developing AI tools and applying a quality-first approach to ensure safe, effective use of AI in GxP-regulated environments.

In this episode, Tim and Oeystein delve into the challenges of adopting AI in regulated settings, the complexity of validating GenAI tools, and the transition from traditional processes to AI-augmented systems. They also explore Oeystein’s work with the IMPALA Consortium and the importance of cross-industry collaboration to identify and scale high-value use cases for Generative AI.

Before his current role, Oeystein served as a Product Owner in Analytics at Merck IT, building analytics platforms and integrating data science across systems. He also contributed as a Machine Learning Subject Matter Expert to TransCelerate’s Intelligent Automation Group, advancing AI applications in pharmacovigilance.

Oeystein brings a rare blend of technical expertise and regulatory insight. He’s passionate about helping teams adopt AI responsibly and transparently—ensuring innovation aligns with quality across the pharmaceutical landscape.

I really think [the Copilot] tools are great in the sense that it allows you to automate out a lot of the boring, non-important parts of your life, and it gets you to focus on the things you’re good at. And it removes some fatigue and allows you to just focus on what matters.”