Quality by Design Is No Longer Enough: Why Biotech Now Needs ‘Quality by Intelligence’ to Scale Safely

 

For more than a decade, Quality by Design has been seen as the modern standard for building quality into medicines and therapies from the ground up. It replaced reactive inspection-driven thinking with quality as a design principle. In Europe and the UK, it is now considered a baseline expectation for any serious late-stage biotech. The challenge today is that QbD no longer differentiates. It no longer protects. In a maturing regulatory environment, where the dialogue between regulators and companies is becoming more forward looking, quality is evolving again. What matters now is not simply whether a company can demonstrate design-level intention, but whether it can operate with intelligence: the ability to anticipate and navigate quality risk dynamically, in real time, across complex development and scale-up environments.

At HRS, this is exactly where we are seeing the next line of capability divide. The companies that will be resilient through commercial transition are those whose quality function is not just compliant but intelligent. This does not mean more control. It means more foresight.

 

The shift in expectations: regulators, investors and health systems

Regulators in Europe and the UK are increasingly looking beyond the quality system itself toward the calibre of thinking behind it. EMA and MHRA reviewers want to understand how quality leaders arrive at their decisions, not just which procedure they followed. There is a growing expectation that organisations can demonstrate learning agility, not just documentation.

The trend is reinforced by broader system pressures. Health technology assessment bodies are scrutinising evidence generation earlier. Supply chains are more digitised and more interdependent. Risk can emerge from a partner, a data interface, a technology choice or a manufacturing method as easily as from a process deviation. The speed at which risk can move across a system has accelerated, but in many organisations the quality mindset has not kept pace.

Quality by Intelligence is emerging because the environment around quality has changed. Complexity has outgrown linear controls. Regulators are increasingly looking for judgement, not merely adherence.

 

What Quality by Intelligence really means

Quality by Intelligence is not a new framework. It is a capability shift. It is what happens when the quality function becomes an organisational sensor rather than an endpoint reviewer. QbInt is characterised by pattern recognition, early risk translation, and a more anticipatory relationship with both data and decision making.

In practice, it looks like this:

• Quality leaders using real world operational data to shape forward risk mitigation.
• Quality not sitting at the end of development cycles, but at key decision points upstream.
• Learning loops that drive insight rather than static risk registers.
• A dialogue with regulators that evidences thinking, not just compliance.

This is a meaningful cultural distinction. Quality by Design ensures intended control. Quality by Intelligence ensures evolved control.

Where most late stage biotechs are struggling

Across the UK and European market, there is a recurring pattern we see from a talent and leadership perspective. Many organisations now have sufficiently mature systems, but not sufficiently mature capability. The technology is modern, yet the internal quality dialogue remains procedural. The QMS is digital, but the leadership mindset is still analogue.

There are three common pinch points:

1. The leadership bandwidth gap – Quality leaders are stretched between overseeing system implementation and strategic foresight. One tends to crowd out the other.
2. Data without insight – Organisations have data lakes or dashboards, yet they lack the interpretive capability required to turn information into intelligence.
3. Talent depth – The market has many strong operational QA professionals, but a smaller pool of quality leaders able to act as strategic risk translators.

This is where the industry divide is becoming visible. Inspection readiness is no longer just a systems question. It is now also a capability question.

 

A human capital issue, not a compliance issue

From HRS’ perspective, the most important shift is that QbInt is fundamentally people-led. Tools are helpful, but capability drives maturity. The companies that are moving furthest ahead are those investing in quality leadership talent with a broader skill set. This now includes:

• Systems thinking rather than linear problem solving
• Data literacy across digital manufacturing and process analytics
• Comfort operating commercially as well as technically
• The confidence to influence early development choices
• Cross-functional credibility rather than siloed governance

In short, the modern QA leader needs range. Not additional compliance depth, but expanded strategic breadth. This is the profile now emerging in the most inspection-ready organisations.

The challenge is that this profile is scarce. In the UK and EU talent market there is a structural shortage of leaders who combine regulatory maturity with digital fluency and translational judgement. The constraint is therefore not adoption of Quality by Intelligence, but access to capability that can deliver it.

 

What good looks like

When quality is intelligence-led, you can see the difference in the organisation long before inspection. Quality becomes a source of foresight, not a gatekeeper of decision making. It informs strategy, rather than reacts to it. In the strongest organisations:

• Data is used to anticipate not investigate
• Quality is present in early governance, not late-stage sign-off
• Risk conversations are about probability and consequence, not only procedure
• Regulators experience quality as a thinking discipline, not an administrative one

This creates confidence not just for regulators, but for boards and investors. Leadership maturity becomes observable. The organisation can demonstrate that it understands its own risk posture in motion, not just on paper.

 

The strategic advantage

For late stage biotechs, moving from Quality by Design to Quality by Intelligence is now a matter of resilience. As commercial transition intensifies scrutiny, it is the organisations that can show quality thinking rather than quality documentation that will retain trust. This is not a technical pivot. It is a leadership one.

As a talent partner to the sector, HRS sees this transformation from the inside. The companies progressing most effectively are securing the next generation of quality leaders before they need them, rather than once a gap has already exposed risk. They are thinking of quality as capability building, not system building.

Quality by Intelligence is the next maturity stage because the future of quality is not control. It is foresight.