About me

My name is Mateusz Walczak. I am a life sciences IT Quality and Compliance professional specializing in AI governance, AI validation, GxP compliance, and risk management, with over 20 years of experience in the pharmaceutical, biotechnology, and life sciences industries.

Throughout my career, I have worked with biotech startups, mid-sized companies, and global pharmaceutical organizations, combining hands-on technical expertise with strategic quality and compliance responsibilities. My background includes more than 15 years in Computerized Systems Validation (CSV), IT Quality Assurance, supplier oversight, and regulatory compliance across manufacturing, clinical, and enterprise IT environments.

I have led and supported validation and quality initiatives involving Manufacturing Execution Systems (MES), ERP platforms, clinical systems, SaaS solutions, industrial automation, and enterprise IT services. This experience has given me a broad perspective on how technology, business processes, regulatory expectations, and organizational governance interact in practice.

AI Strategy, Governance and Compliance

In recent years, Artificial Intelligence has become a central focus of my professional work and research, particularly its strategic adoption and governance within GxP-regulated environments.

I have collaborated with multiple organizations on the development and refinement of global AI validation policies, risk assessment methodologies, quality procedures, and governance approaches. My work focuses on translating emerging AI capabilities and enterprise-level strategies into practical, risk-based frameworks that can be implemented within existing quality management systems.

I am particularly interested in the challenges posed by generative AI, foundation models, and agentic systems, and how their characteristics affect established concepts of validation, reliability, data integrity, human oversight, and regulatory accountability.

My perspective is that AI does not necessarily require organizations to reinvent their quality systems. Established GxP principles provide a solid foundation, but their application requires critical thinking, an understanding of AI-specific uncertainties, and the ability to distinguish genuine regulatory risks from unnecessary procedural complexity.

Education and Professional Development

In 2024, I completed an Executive MBA, with my thesis "From Risk to Opportunity: Strategic Mitigation of AI/ML Challenges in GxP Settings." My research examined the strategic, operational, and regulatory challenges of implementing Artificial Intelligence in life sciences organizations.

I subsequently completed the AI Ethics, Regulation, and Compliance Programme at Saïd Business School, University of Oxford, expanding my knowledge of international AI regulation, governance frameworks, ethical considerations, and AI assurance.

These experiences strengthened my interest in the intersection of technology, organizational strategy, and regulatory governance, complementing the practical knowledge developed throughout my professional career.

Research and Professional Perspective

Alongside my consulting work, I actively explore how established GxP methodologies can be applied and adapted to emerging AI technologies.

My research and publications focus on subjects such as AI risk assessment, validation strategies for generative and agentic AI, behavioral uncertainty, human oversight, and the evolving relationship between traditional CSV, Computer Software Assurance (CSA), and AI governance.

I aim to bring a critical, evidence-based perspective to these discussions, questioning assumptions where necessary and translating complex technical and regulatory concepts into practical approaches accessible to Quality, Validation, IT, and business professionals.

I believe effective AI governance is not about introducing complexity for its own sake. It is about applying sound judgment, understanding technology, and managing uncertainty in a way that supports both compliance and innovation.

Let's Connect

I welcome discussions with professionals and organizations exploring AI strategy, GxP compliance, validation, and emerging regulatory challenges.

Whether you're developing an AI governance approach, navigating a complex validation challenge, or simply interested in exchanging perspectives on the future of AI in regulated industries, I'm always open to a meaningful conversation.

Contact: [email protected]