QuidelOrtho Strengthens Leadership Team With Appointments of Senior Vice Presidents for Global Quality and Clinical & Regulatory Affairs

Rhea-AI Summary

QuidelOrtho (NASDAQ: QDEL), a global in vitro diagnostics provider, has strengthened its leadership team with two key appointments. Devon Burek joins as Senior Vice President of Global Quality, bringing over 20 years of experience from Roche, while Sergio Gadaleta becomes Senior Vice President of Clinical and Regulatory Affairs, leveraging his experience from BD, 3M, Johnson & Johnson, and the FDA.

Burek will focus on streamlining global quality approaches and enhancing operational effectiveness. Gadaleta, who holds a PhD in chemistry, will lead the company's global clinical trial strategy and regulatory submissions, working closely with the FDA and global health agencies.

Positive

• Strategic strengthening of leadership team with experienced executives from major healthcare companies
• Addition of regulatory expertise to enhance FDA and global health agency relationships
• Enhancement of quality control systems through experienced leadership

Negative

• None.

New executives bring deep expertise to elevate quality and accelerate innovation across global operations

SAN DIEGO, July 7, 2025 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has appointed two industry-leading executives to its leadership team. Devon Burek joins the Company as Senior Vice President of Global Quality, and Sergio Gadaleta joins as Senior Vice President of Clinical and Regulatory Affairs. These hires reflect the Company's continued investment in operational excellence, product quality and regulatory innovation to support global growth.

As SVP of Global Quality, Burek will lead the Company's quality organization with a focus on creating a streamlined, global approach that elevates product quality and enhances operational effectiveness. Prior to joining the Company, Burek spent over two decades at Roche in quality leadership roles across diagnostics and R&D.

"Devon brings a rare combination of scientific insight and enterprise-wide quality expertise," said Phil McLellan, Chief Operations Officer, QuidelOrtho. "She is exactly the kind of leader we need to drive long-term impact as we pursue continual innovation to develop and refine high-quality products and solutions that provide the speed, accuracy and accessibility our customers need across the healthcare ecosystem."

Gadaleta, as SVP of Clinical and Regulatory Affairs, will lead QuidelOrtho's global clinical trial strategy, regulatory submissions, and engagement with regulatory bodies, including the U.S. Food and Drug Administration ("FDA") and global health agencies. His experiences span senior roles at BD, 3M, Johnson & Johnson, and the FDA. He holds a PhD in chemistry and is recognized for his ability to drive innovation while navigating complex global regulations.

"Sergio's scientific rigor and strategic mindset make him an important addition to our team," said Jonathan Siegrist, Executive Vice President of R&D and Chief Technology Officer, QuidelOrtho. "His leadership will be instrumental in guiding our innovations through clinical and regulatory pathways and into the hands of healthcare providers worldwide."

As we continue driving productivity and efficiency within our R&D team, these additions underscore QuidelOrtho's commitment to building a high-performance organization rooted in scientific excellence, customer trust and global scale.

QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.

About QuidelOrtho Corporation

QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day. 

Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic.

Building on its long history of innovation, QuidelOrtho works with global healthcare customers to advance diagnostics, where insights and solutions seamlessly connect, illuminating a clearer path for informed decisions.

Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com

Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com

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SOURCE QuidelOrtho Corporation

FAQ

Who are the new senior executives appointed at QuidelOrtho (QDEL)?

Devon Burek was appointed as SVP of Global Quality and Sergio Gadaleta as SVP of Clinical and Regulatory Affairs.

What is Devon Burek's background before joining QuidelOrtho (QDEL)?

Devon Burek spent over two decades at Roche in quality leadership roles across diagnostics and R&D.

What will be Sergio Gadaleta's responsibilities at QuidelOrtho (QDEL)?

Gadaleta will lead global clinical trial strategy, regulatory submissions, and engagement with regulatory bodies including the FDA and global health agencies.

What is Sergio Gadaleta's professional background?

Gadaleta has held senior roles at BD, 3M, Johnson & Johnson, and the FDA, and holds a PhD in chemistry.

How will these appointments impact QuidelOrtho's operations?

The appointments will help streamline global quality approaches, enhance operational effectiveness, and guide innovations through clinical and regulatory pathways.