About me

My name is Mateusz Walczak. I specialize in GxP compliance, Computerized Systems Validation (CSV), and IT Quality Assurance, with experience spanning pharmaceutical, biotech, and life sciences industries. Over the years, I’ve worked with startups, mid-sized companies, and global enterprises, helping them navigate the complexities of GxP-regulated IT systems, automation, and data integrity.

My expertise covers manufacturing and clinical systems, ERP implementations, MES, SaaS solutions, and IT service management platforms. I have successfully led validation and compliance strategies across diverse technologies, ensuring they meet regulatory expectations while staying efficient and scalable.

Beyond traditional CSV, I have a strong interest in AI governance and risk management, particularly in the context of GxP compliance and regulated environments. I explore how AI-driven solutions can be implemented responsibly, balancing innovation with regulatory oversight and risk mitigation. In 2024, I authored and successfully defended a thesis titled "From Risk to Opportunity: Strategic Mitigation of AI/ML Challenges in GxP Settings" as part of my Executive MBA Poznań-Atlanta post-graduate studies. Building on that foundation, in 2025 I completed the Oxford AI Ethics, Regulation, and Compliance Programme at Saïd Business School, University of Oxford, where I explored global AI regulations, governance frameworks, and AI auditing practices.

I am always open to discussions on compliance strategies, AI governance, and validation best practices. Let’s connect!