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Charlotte Oom, VP Quality, Clinical & Regulatory Affairs

“There is no better way to grow in leadership than through real life experience, working closely with diverse teams and individuals, each with their own strengths, perspectives, and challenges.”

 

Q: Can you briefly introduce yourself and a bit about your background?

I live just outside Lund in Sweden and have been with CellaVision for 13 years. Over this time, I’ve held roles ranging from Test Leader to Development Manager, then Director of QA/RA, and for the past year, I’ve been part of the Executive Management team as VP of Quality, Clinical, and Regulatory Affairs. 

I have always been fascinated by both engineering and the human body, which led me to study MSc in Engineering Biology at Linköping Institute of Technology. From a young age, I also loved writing, whether creating my own newspapers to sell to neighbors or keeping detailed diaries. Combining that with my passion for engineering and healthcare makes my work in quality, clinical, and regulatory affairs at CellaVision a perfect fit.

Charlotte Oom

 

Q: What was it about CellaVision that made you decided to join? 

When I first encountered CellaVision, it was during a short consultancy assignment. I was immediately drawn to the office atmosphere: a mix of dedicated, smart colleagues working toward shared goals, yet with a family-like feel that welcomed humor and camaraderie. Joining as a Test Leader was an easy decision. 

Since then, I have grown through each role thanks to the trust and empowerment from both managers and colleagues, which allowed me to take on responsibilities that challenged me and helped me develop professionally and personally.

Q: What motivates you most in your daily work – both on a professional and personal level? 

What drives me daily is achieving goals, whether it’s successfully leading a submission to a regulatory authority or running an ultra-marathon. Trust is also essential to me, and I want to be able to trust my colleagues and feel that they trust me. 

In my current role overseeing QA, RA, and Clinical Affairs, I coordinate teams to ensure that quality standards are upheld, regulatory requirements are met, and clinical studies are carried out efficiently across the globe. By doing so, I directly support CellaVision’s mission of advancing laboratory workflows and diagnostic certainty, making certain that our products are safe, effective, and serve healthcare professionals and patients alike.

One of the projects I’m particularly proud of is the CE certification of the Bone Marrow Aspirate Application. I was involved from the early development stage as Development Manager, and by the project’s conclusion, I oversaw both Clinical and Regulatory Affairs teams. 

The collaboration across multiple teams, the long hours, and the intense documentation requirements were challenging, but achieving the internal CE-mark deadline was a true accomplishment and a great example of how teamwork and dedication drive meaningful results.

Q: How have you developed, professionally or personally, since you started working at CellaVision? 

Over the years, I’ve grown as a leader, learning to adapt my style to different teams and situations while empowering individuals to take ownership of their work. Challenges, such as taking on new teams multiple times, have strengthened my understanding of team dynamics and taught me how to bring out the best in each person. 

CellaVision’s culture of warmth, dedication, and mutual trust makes it possible to continually learn, innovate, and contribute to both organizational and personal growth.

Q: What hobbies, interests or passions do you have that shape who you are? 

Outside of work, I am passionate about sports and family life. I have always been active, from playing soccer in my youth to running, and during the past years, due to my son's passion for cycling, I bought a mountain bike and got hooked. I also cheer on my other son in hockey, enjoying being part of a supportive sports community. 

A fun fact about me is that I recently earned my heavy trailer license so I can transport our caravan to national mountain bike competitions, a challenge that showed me that determination and practice could make something I previously considered impossible possible. Spending time with my family while pursuing active hobbies is what truly shapes who I am.

Charlotte Oom, 

VP Quality, Clinical & Regulatory Affairs

Based in Lund, Sweden