AbbVie’s Sean McEwen on the Importance of Quality Assurance and Problem-Solving

Originally published at stories.abbvie.com. Sean McEwen is AbbVie’s vice president of quality assurance. AbbVie ranked No. 15 on The DiversityInc Top 50 Companies for Diversity list in 2021.

 

AbbVie’s Sean McEwen has a history of problem-solving and facilitating quality assurance. Whether it was fixing television sets for his family’s business, his background in engineering biopharmaceuticals, or even him rallying his Gaelic football team to a winning victory, McEwan has learned from past experiences, all of which has contributed to his ability to solve problems — an ability all the more important considering his role as AbbVie’s VP for Quality Assurance. AbbVie recently spoke with the Ireland native, who gave a glimpse into what it’s like holding the great responsibility of providing quality therapies to patients.

 

Your career has been based in engineering, specifically chemical engineering. How did you become interested in this area of science?

My dad was an electrical engineer and teacher at a local college. As a sideshow, my father and brother fixed anything electrical. We grew up fixing electronics through his electrical repair business. It was televisions at Christmas time. The rest of the year, you would walk into our house and it smelled like fish from the marine and sonar equipment that needed repairs from the fishing industry in Donegal. I realized I had a passion for problem-solving, and it was my father who suggested chemical engineering. I did that and my brother focused on the televisions and sonar.

 

You attended Queens University of Belfast. How did you decide to work in the pharmaceutical industry?

I almost went to work at a nuclear power station working in renewable energy, but I had the privilege of pharma recruiters coming to my university and giving me a better sense of the positions available in chemical engineering. I started working in pharma manufacturing the day after I graduated and never looked back.

My first role was as a process engineer, very hands-on in a highly regulated, highly-controlled environment. The first six to seven years helped me understand the importance of getting the process right to manufacture pharmaceuticals. It’s not like a plastic toy your child plays with for a few months that might break. There is no room for error with patients – they deserve nothing less than best in class.

 

Quality sounds simple, and yet can be difficult for others to understand just how complex your work is. What don’t people understand about quality and manufacturing?

I tell my kids, I oversee the quality of manufacturing, testing, release and distribution of products and work with great people to do it. For everyone, it’s easy to see a tablet, capsule or vial, but to create that medicine requires so much work. For just one molecule, it might require over 30 complete manufacturing steps. This is novel chemistry or biology, and my job is to make sure we are consistent when we recreate the 30 steps each time, and with the same high level of quality. Batch one should be the same as batch 1,000 when it comes to quality.

I recently watched a documentary on the Challenger space shuttle explosion, and it was just one O-ring that failed. To me, that is an easy way to understand how one small part not working can impact the entire quality of a product in a massive way.

 

There’s a lot of planning that goes into manufacturing and quality. What’s it like to pivot quickly, for example during the pandemic or during a natural disaster?

We’re always anticipating future challenges and planning for emergencies. Every one of our facilities has a plan B and plan C and so on. We look at history and see that things can go wrong, and we learn from that. If you’ve got good engineering built into those designs, then you do a lot of risk analysis, contingency planning, and anticipate what could go wrong. It’s an endless cycle to make sure the small things don’t trip you up.

I believe my quality team has the toughest job because if there’s one small mistake, it could mean rejecting an entire batch, and we can’t have that because it ultimately impacts a patient who is sick or is trying to avoid serious symptoms. We strive for “right first time” with zero defects and 100% accuracy for every product, every day, every week, every month, every year. That’s redundancy with 100% accuracy.

 

Your passions are history and Gaelic football. Do you find those two things play a role in how you approach quality?

Absolutely. There’s not a day I don’t think about Gaelic football and playing for my boyhood club of St. Eunans. I love that sport and its ethos. Along the way, I learned about the criticality of teamwork, humility, and community. I think about the best teams I played on and how we didn’t have absolute stars. It was about the collection of people with the same talent and drive, but we brought the best out in each other. That’s the secret sauce to any team. Within the quality team at AbbVie, we motivate each other in providing the highest quality products and outstanding service to help the patient.

With history, it’s so important because it can be frustrating to see it repeat itself. I believe we need to use history as a tool and education to get to the bottom of a problem. We use this thinking in our manufacturing process to help assure quality. I’d like to see more of this thinking when it comes to racial justice as a society; we need to look at the past, learn from it, and do better.

 

So much of your life has been problem-solving and looking at science and math. Is there a personal connection to the work you do?

I come from a big family. I’m the youngest of seven. I had five very influential older sisters, one older brother and we are all very close. One of my sisters passed away from cancer when she was just 39 years old. It was devastating for us and her family. I like to think her story would be different today because there’s been so much progress in the science and what we can do for cancer patients.

 

How do you describe your leadership style today?

We have this great culture at AbbVie. It’s genuinely all about the team and that’s important because we truly believe quality, like safety, is a collective, global priority. It’s everyone’s responsibility to speak up, ask questions, and come forward with ideas on any quality improvement, and we like to operate that way. I make no apology for being intense and focused on quality improvement but also find it is so important to be inclusive and open.

We are all on a relentless journey of continuous improvement. I take the responsibility extremely seriously of creating quality products for our patients who depend on them so they can work and take care of their families.

I never forget that.

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