When Outsourcing Goes Wrong: How to Spot a Failing CDMO Relationship Before It Costs You a Launch

When relationships with contract manufacturers break down, the cause is rarely just the contract manufacturer. A panel of three sponsor-side executives examined the warning signs, the internal failures, and the governance models that determine whether a difficult relationship recovers or ends.

At CDMO Live Europe 2026, a session, moderated by Raman Sehgal of the Molecule to Market podcast, brought together three buyers: Stefan Bouckaert, a Quality and Operations Leader who spent 20 years at Johnson & Johnson overseeing 170 contract manufacturing organizations and 5,500 suppliers; Nick Wark, Head of External Manufacturing and Strategic Partnerships at Ferring Pharmaceuticals, overseeing several dozen contract manufacturers; and Oksana Vodovska, Business Development Manager at Sopharma, a regional generics company that selectively outsources alongside its own production facilities.

The Warning Signs

All three panelists pointed to KPIs and operational dashboards as the baseline for early detection, but the most telling signal is harder to quantify. Bouckaert explained he looks for visible gaps between what leadership says and what happens on the shop floor. “If you start to see there is a discrepancy between what’s being said at a higher level and what’s happening at the floor level, for me, there are alarm bells.”

Wark framed it in terms of firefighting frequency. If corrective actions keep addressing symptoms rather than root causes, and issues keep recurring at inconvenient moments, something structural is not working. Vodovska added that smaller sponsors face a specific version of this problem. With less leverage than large pharma, they are less likely to push back when vague updates and subtle delays first appear, which means problems compound before they are surfaced.

The Buyer’s Role

The panel highlighted that sponsors can contribute to relationship failures at least as often as CMOs do. Vodovska described a case where her team was prepared to blame the CMO before an internal review revealed that procurement and technical functions had not been aligned in the first place. For smaller companies, she noted, wearing multiple hats slows decision-making and reduces the ability to realign quickly when things drift.

Wark argued that slow decisions are largely a governance problem, not a capacity problem. His expectation is that teams engaging directly with partners are empowered to resolve 90% of operational issues on the spot, without routing back through layers of internal approval. “If you go into a meeting and you need to ask for permission later, then that doesn’t work.” He added that showing up to partner meetings with quality, supply chain, and commercial functions present together, rather than sending a single representative to relay views from others, removes a significant source of delay and misunderstanding.

Bouckaert reinforced this from a different angle. At J&J, a recurring failure mode was procurement moving ahead with commitments before quality and operations had fully aligned. When a CMO with a strong small-molecule track record was pushed to expand into an area beyond its current capability, the ambition was there, but not the execution capacity. He cited one COVID-era example where a CMO redirected expertise toward vaccine filling, and its performance across other work visibly deteriorated. “The signals were too late.”

Handling the Difficult Conversation

Wark challenged the premise of the question itself. “If you have set up a model that is in the spirit of a collaborative partnership, then there are no difficult conversations. They are just conversations that you need to have about topics that may be difficult.” Regular engagement, shared KPI visibility, and a relationship built before problems arise are what make escalation manageable. A difficult conversation only becomes genuinely difficult if it is also the first conversation.

Bouckaert described a concrete example of holding the line internally: arriving at a performance review where the agenda moved directly from quality failures to new business opportunities. He told the room he would not attend further meetings structured that way. That boundary, he said, helped shift the dynamic and eventually moved the relationship toward a more workable position. Vodovska’s closing note was practical: preparation across scenarios, cross-functional input before any difficult meeting, and a baseline of personal trust with counterparts. “If you have this built-in relationship, you can overcome more obstacles.”

Takeaways

  • Frequent firefighting without structural root-cause resolution is a reliable early signal that the relationship model is not working.
  • Discrepancies between senior-level messaging and shop-floor reality at a CMO warrant escalation of your own technical resources into the site.
  • Sponsor teams that engage partners as a single, cross-functional unit, quality, supply chain, and commercial together, resolve issues faster and send clearer signals.
  • Empowering operational teams to make 90% of decisions without internal approval layers is a deliberate governance choice, not a default outcome.
  • Regular, structured engagement turns potential escalations into routine conversations; the hardest discussions arise when they are also the first ones.