By Raf Lemmens
”QA is like a wet blanket.”
What do you think when someone says something like that?
The other day I was thinking about an internal workshop with our colleagues. We would discuss what a QA Manager actually does, what we can offer our customers. It sounded simple – but when we started talking, we realized that it is much more difficult than we thought. Because the QA role is broad. It spans setting up quality systems, complying with regulations, batch release, supplier management, audits, managing process changes and deviations, sponsor oversight, validation, certifications, gap analyses, management, planning, change management… and much more. And precisely that breadth makes it difficult to put a clear bullet list. Breadth is a strength – but also a challenge. Because how do you sell QA consulting services when the value lies in the whole? How do you explain that you know a little bit of everything, and that that’s exactly what makes the difference?
A dictionary might say, ”A QA Manager is responsible for developing, implementing, and monitoring processes that ensure that products or services meet quality standards and regulations.”
And that sounds simple, right? But the reality is far more complex – and that’s where the challenge lies. QA isn’t just operational. It is strategic, essential to a company’s success – especially in the startup phase. Strong quality work builds trust, reduces risks and creates conditions for innovation and scalability. And it requires more than processes and documents – it requires us to engage the entire organization. Everyone has to contribute, because as a company, we simply can’t afford to make mistakes.
And the value? QA doesn’t have to be that wet blanket that is put over the business. On the contrary – it should be a catalyst to control the risks and focus on what really matters: the patient in the end.
So how do you package QA consulting services to show this breadth? Should we highlight the ability to create wholeness, to be the bridge between regulations and business goals, to combine attention to detail with strategic thinking. Then it is not a list of points, but a story of value.

