Quality & Regulatory Leadership in 2026: How the Function Is Evolving and What Comes Next

To understand how the quality and regulatory landscape is changing, we spoke with two industry executives: Suat Kumser, Advisory Board Member and Former Head of Global Integrated OSD and API Manufacturing Operations at Viatris, and Irving Ford, former VP, Quality at Adaptimmune. 

Their perspectives reveal a function undergoing rapid transformation – driven by digitalization, globalization, and organizational redesign.  

How has the quality and regulatory space changed over the last 5 years? 

Irving Ford: AI is everywhere in quality and regulatory. All quality and regulatory functions today are exploring: how do we implement AI, how do we validate it, and how do we demonstrate that it is delivering the intended impact? Given the growing momentum around AI, the FDA recently published guidance on how to use it to help support regulatory decisions around a drug’s safety and effectiveness. 

Another shift in the industry is the push from the FDA for quality and regulatory to be an independent unit. Many organizations have been focusing on integrating quality and regulatory into supply chain to streamline the function and reduce headcount. However, in doing so they are not acknowledging the pivotal role quality must play in drug development. Thus, the FDA is responding to this shift, which is causing significant turmoil in the sector.  

Suat Kumser: Similar to most other industries, during COVID, quality and regulatory shifted to using digital tools for almost everything. This in turn accelerated many technological advancements, which the pharmaceutical industry has taken advantage of to improve many of its processes. For example, previously, elements of quality and regulatory processes were completed manually, whether it was the data collection itself or the processing that followed. Now, most quality and regulatory functions are using fully automated processes, which often includes AI, to monitor product quality in real time.   

JM Search Perspective: AI is transforming the quality and regulatory space, supercharging a move toward greater process automation, which was accelerated by the pandemic. This comes as companies are grappling with how to best structure their quality function. Organizations are navigating competing pressures from the FDA, which is driving for an independent quality function, and company leadership, which is often focused on reducing headcount and integrating quality into supply chain.   

What are you seeing as the biggest trends in quality and regulatory heading into 2026? 

Irving Ford: Collaboration across companies is becoming increasingly common. In the past, enterprises would rarely discuss the challenges they were facing. If one pharmaceutical company had a problem, they would not dare reach out to a competitor to say, “hey, are you observing something like this too?” Today, companies are more open to collaborating because even though they are competitors, they are doing similar things.  

Suat Kumser: Regulators are aligning standards internationally, which reflects the increasing globalization of the quality and regulatory space. Between the current Good Manufacturing Practices (cGMP) across the EU, the FDA in the United States, and other regulatory agencies, we are seeing more similarities than ever before. Of course, there are differences and nuances between each governing agency, but more frequently, there is a recognition of standard best practices that all pharmaceutical organizations must follow.  

JM Search Perspective: Both public agencies and private companies are leaning into the benefits of strategic collaboration, recognizing the advantages of working with entities facing a similar challenge or chasing a similar goal.    

How do you see talent needs changing as a result of these shifts? 

Irving Ford: To thrive in today’s environment, organizations need high-performing teams at all levels. Increasingly, that means prioritizing leaders who are a strong cultural fit rather than exclusively focusing on technical skills. If a person doesn’t have a certain technical skillset, but their mindset is what the company is seeking, the organization will take the approach of: “we should hire this person because we want to keep our culture in place and we can always upskill them on them on the technical side.”  

Organizations often use the word culture to mean a lot of things. A high-performing culture in a pharmaceutical organization is one where everyone understands their role, and although quality must be independent within the organization, everyone, from the executives to those on the floor, understands what quality and regulatory does and why it matters for the organization.  

Suat Kumser: Having an enterprise global mindset has become much more important. Due to the prevalence of remote work, more than ever, colleagues from around the world are collaborating from a distance. This requires a different skillset in terms of listening, communicating, and understanding cultural differences.  

In addition, in the past, talent was always expected to be highly specialized. For some positions, this is still true. However, today’s leaders need to have a broader view and understanding of the entire organization because of the highly global nature of the working environment. 

JM Perspective: Talent expectations have evolved dramatically. In an increasingly complex, global environment, today’s organizations seek candidates that are a culture-fit rather than technical-fit and can help to build high-performing teams across regions. Organizations are looking for leaders who possess a broader range of skills rather than a highly specific skillset and can flex with the organization’s changing needs and challenges.   

What do you see as the biggest challenges facing the quality and regulatory space today? 

Irving Ford: Many companies today face challenges around succession planning. When one person in an organization possesses all the foundational knowledge and expertise in a certain area, the company is vulnerable in the case of turnover. With increasing global competition, top talent is quickly being recruited elsewhere. Thus, it is critical for quality organizations to cross train their teams to avoid exposing themselves to this type of risk. 

Suat Kumser: Geopolitical uncertainty has created vulnerability for organizations dependent on sourcing materials and products from other countries. No country can produce everything needed to operate in this global environment, so a disruption in one country can reverberate around the world. 

JM Search Perspective: Organizations must protect themselves by having a risk mitigation strategy to deal with unexpected events, whether it may be geopolitical uncertainty or employee turnover. 

As quality and regulatory functions continue to evolve, effective leadership will be the cornerstone of future success. AI and automation are transforming how work gets done, but technology alone cannot close structural or talent gaps. The organizations that thrive will be those that cultivate globally minded leaders, develop true succession depth, and anticipate disruption before it strikes.