Beyond Auditing: How Qualifyze Proactively Manages Risk in Uncertain Times

“The pharmaceutical industry is very good at being reactive. If something happens, they have very clear processes, but they’re not so good at essentially anticipating certain changes.” – David Schneider

David Schneider, Founder & CEO of Qualifyze, brings more than a decade of experience working in investment banking (JP Morgan), Fortune 500 companies (BASF), and management consulting (McKinsey). He now leads Qualifyze, a company transforming supply risk management in the pharmaceutical industry.

With operations across Frankfurt, Barcelona, and now Jersey City, Qualifyze serves around 1,400 pharmaceutical companies globally and has inspected over 4,000 production sites worldwide.

In the latest PharmaSource podcast, David and Qualifyze’s Chief Product Officer Martin Lehmann discuss how data-driven approaches can help pharmaceutical supply chains adapt to geopolitical pressures and uncertainty.

The critical shift in the role of quality compliance

The pharmaceutical landscape is undergoing a fundamental transformation in supply chain strategy. According to David, the industry has historically excelled at responding to problems through established protocols, but struggles with anticipating disruptions before they materialise.

“What we see from our client side is they’re struggling with more or less fragmented supply networks,” David notes. “In the past there was a stronger focus on having a very efficient supply chain. This focus is shifting more towards having a resilient supply chain, that is able to adjust quickly. It might not always be the cheapest option, but essentially the one that keeps you maintaining the business.”

This strategic pivot is driven by increasing geopolitical tensions, regulatory pressure and environmental risk, hence the growing necessity to diversify supplier bases. Quality compliance is consequently evolving from a routine box-ticking exercise to becoming a strategic partner for procurement and supply chain professionals.

Breaking down data barriers

One of the most significant obstacles pharmaceutical companies face is the compartmentalised nature of their data across departments. Martin explains that despite technological advances, many organisations still struggle to integrate critical information. The consequence of these information barriers is that supply-related decisions are often based solely on a company’s internal data, lacking the industry-wide perspective that could inform superior decision-making.

“Several of our leading customers are taking quite huge steps to break those silos. They are focusing on sharing objective data to guide both decision-making on the quality side as well as the supply chain side more broadly,” Martin says. “This means creating a more collaborative and data-driven environment to increase predictability, improve outcomes and reduce costs.”

The unique CDMO challenge

Contract Development and Manufacturing Organizations face distinctive challenges in today’s evolving pharmaceutical supply chain environment. David highlights that CDMOs must navigate conflicting customer demands while maintaining operational integrity: a high level of flexibility is expected of them.

“CDMOs struggle where customers want them to operate exactly under their own procedures in order to continue working with them. At the same time, because CDMOs work for many different ones, it’s not something that they can really do,” David explains.

This delicate balancing act is further complicated by CDMOs’ more extensive and complex supply chains, which typically translate into longer lead times, higher quality costs, increased inventories, and greater exposure to supply risks.

“Regulators are increasing the bar as to where GMP really starts in the supply chain, making tier two and beyond visibility actually more important,” says David. “Without digital solutions and better risk visibility, these pressures will likely intensify before they improve.”

The power of predictive intelligence

Qualifyze is evolving beyond its origins in supplier auditing to leverage its vast data repository for comprehensive supply chain risk management. David explains that the company is serving over 1400 life science companies worldwide, performing between 100-200 new audits each month. These data give Qualifyze a pool of  unique insights unavailable elsewhere.

“We saw that our quality clients started looping in colleagues from other functions like supply chain and procurement. ,When we started seeing this pull from our quality counterparts, we embarked on building a new product to address a broader need,” David says. “We’re providing the means for managing supplier risks more proactively, in that we help quality, procurement and supply chain teams to collaborate better through a common set of data. We have the unique information to rate suppliers based on their compliance risk and benchmark them across the industry. This is a capability no single life science company could achieve on its own, and this is where we can serve them. ”

Martin elaborates on the practical application: “Imagine a head of quality logging into the platform to assess the key risks they’re facing across the most critical suppliers. Based on that, they can make better decisions around how to focus their own audit planning or resources towards the right risks and the right suppliers.”

Similarly, procurement leaders can access the same information to understand the quality profile of potential suppliers early in the selection process or prepare for strategic review discussions with existing suppliers.

Transforming supplier risk management: from reactive to proactive

When asked about success metrics for their new platform, David emphasises that customer outcomes will be the ultimate measure. “ True success comes when we empower our clients to not only spot risks early, but to proactively address them—and even prevent them—before they ever have a chance to unfold.

The strategic vision is to enable life science companies to assess not just their highest-risk suppliers, but their entire supply-base through Qualifyze’s comprehensive data analytics. “I hope our clients will look at us as a strategic partner to improve their supplier risk management activities,” David concludes.

Qualifyze are the official podcast sponsor at CDMO Live. Meet the team at the event, 7-8th May, Rotterdam. Find out more