Dr Stefanie Schmidt has been part of PharmaKorell since December 2025 and strengthens our team in Munich as a Senior Consultant. With experience spanning academic research, community pharmacy, industrial pharmaceutical manufacturing, and leadership roles in the quality function of a CDMO, she brings a broad range of perspectives – combining scientific depth with the pragmatism of day-to-day GMP work.

To get to know her and the way she works, we asked Dr Schmidt a few questions: What genuinely helps when making decisions under pressure? Which process improvement is often underestimated, even though it almost always delivers? And which principles, as a QP, remain non-negotiable – even in capacity crunch situations?

Your career path spans academic research, community pharmacy, industrial pharmaceutical manufacturing, and leadership responsibilities in the quality function of a contract manufacturer (CDMO) – and now consulting. How has this breadth shaped your approach to risk assessment and decision-making under pressure?

The variety of perspectives and experiences helps me prioritise flexibly depending on the situation. In some moments, strict compliance with the rules is what matters most; in others, it is a very practical understanding of processes and their limits. Especially in a GMP environment, you quickly see how important it is to bring theory and reality together and to interpret grey areas correctly.

The combination of a scientific background, operational experience, and regulatory understanding now helps me assess risks holistically and make pragmatic decisions that are still technically sound.

Which system or process improvement almost always leads to better outcomes, yet is still frequently underestimated?

One often underestimated but highly effective improvement is the systematic involvement of the employees who work with the processes every day. They know bottlenecks, workarounds, and opportunities and they often provide the quickest “quick wins”. When employees are actively involved in improvement efforts, willingness to adopt and sustain new solutions increases significantly. However, there is often a lack of a clear method to capture experiential knowledge systematically and translate it into improvements.

What hard-earned insight would you definitely pass on?

One important insight, although I suspect it doesn’t really spare anyone detours, is that expertise alone is not enough. What matters is the willingness to make decisions and take responsibility for them. This sense of responsibility does not develop by itself; it grows through practice, reflection, and an open approach to mistakes, which is not a weakness, but a sign of professionalism that builds trust.

Equally important is asking questions rather than staying silent out of uncertainty. Questions prevent misunderstandings and accelerate real learning.

So if there is one thing I would pass on, it’s this: decide courageously, ask curious questions, and learn openly from mistakes.

Which types of customer challenges appeal to you most in your new role as a Senior Consultant at PharmaKorell—and why?

I’m particularly drawn to customer challenges where I can directly apply my experience from pharmaceutical contract manufacturing, especially in the field of sterile medicinal products, to support customers in a very practical way.

At the same time, I’m looking forward to challenges that help me grow both technically and methodologically. The pharmaceutical world is diverse and evolving rapidly. The opportunity to look beyond my previous technical focus, explore new subject areas, and get to know different ways of thinking and working is highly motivating for me.

Ultimately, what excites me most is the mix: a varied “bouquet” of projects, structures, and questions. For me, that variety is what makes the consultant role so appealing right now.

In times of capacity constraints, pressure can increase to release batches particularly quickly. As a QP, what are your non-negotiables? Where do you draw the line, regardless of circumstances?

The role of the QP was intentionally established by the legislator as the final independent safeguard between manufacturing and the patient and that is exactly how I understand it. Medicinal products are a special good, and in the end it is always about people who trust that we take our responsibility seriously. I draw the line where patient safety can no longer be guaranteed beyond doubt. If uncertainties remain, if data are missing, or if risks have not been fully assessed, then I cannot and must not release a batch. This decision must not be influenced by time pressure, commercial interests, or external expectations.