We Proudly Stand for Quality
By Coleen Glessner, SVP, Chief Quality Officer Alexion Pharmaceuticals, Inc.
Last November, the employees featured in the photo above hosted a tour of the building behind them. The building itself is, by all accounts, nothing short of a game changer for all of us who work at Alexion. On that day, I had an exclusive look at our new state-of-the-art manufacturing facility in Blanchardstown, Dublin, Ireland, where many of our rare-disease therapies will be produced. The visit was impressive for several reasons.
Alexion’s new bulk-drug substance facility represents the end result of years of planning and the realization of our manufacturing team’s vision. It also represents a new beginning in how we think about quality in the organization. Rather than auditing our external partners to ensure the quality of our products, we have used “quality-by-design” principles to build in quality from the onset of the product life cycle. Also, this new facility was designed with the patient in mind. Our Operations and Quality teams will shepherd new therapies along their development journey with a precise understanding of where the journey ends: serving patients living with a rare disease. At Alexion, we understand that this is a matter of trust: “When we, in Quality, release a product, our name is on the label,” said Robert Byrne, Head of Quality at College Park, “and that is something we all take very seriously.”
After the tour, I turned to a colleague and remarked how the opening of the new facility felt like that moment when you can finally see the puzzle come together—seamlessly, clearly, and in full color—and how it all makes perfect sense. Alexion brought together everything that was needed to infuse quality into each manufacturing step, knowing that the final step of the journey ends with our patients. And it couldn’t have come at a more exciting time for us as we take on new challenges in the rare disease space that includes expanding our Quality team. (Interested in joining us? Check out available positions here.)
One of the things that first attracted me to Alexion is our strong focus on patients. But it’s not just about developing transformational therapies; it’s about understanding the priorities of patients who live with a rare disease. They need to know they can depend on us for safe, reliable products with uncompromised quality. Donnan, who lives with atypical hemolytic uremic syndrome (aHUS), a rare complement-activation disorder that can progressively damage vital organs, had shared with our employees an important part of his own patient journey: “The quality of a product matters to me as someone living with a rare disease. It allows me to be a dad now and maybe even a granddad one day."
Donnan’s journey is our journey at Alexion and why we proudly stand for quality in all that we do to serve patients.