QuidelOrtho Enhances Leadership with Key Executive Appointments for Quality and Regulatory Affairs

QuidelOrtho Enhances Leadership Team

QuidelOrtho Corporation, known for its innovative in vitro diagnostic technologies, has made significant changes to its leadership by appointing Devon Burek as Senior Vice President of Global Quality and Sergio Gadaleta as Senior Vice President of Clinical and Regulatory Affairs. This move demonstrates QuidelOrtho's commitment to enhancing operational excellence and driving innovation in the diagnostic space.

Leadership Moves to Foster Innovation

Devon Burek: Driving Quality Enhancements

As the newly appointed SVP of Global Quality, Burek will spearhead efforts to refine the company’s quality processes. Her previous experience spans over 20 years at Roche, where she held various leadership positions in diagnostics and research and development. QuidelOrtho’s Chief Operations Officer, Phil McLellan, praised Burek’s scientific insight and quality expertise, asserting that her leadership is crucial for the company’s long-term goals and for developing high-quality products that meet customer needs across the healthcare ecosystem.

“Devon brings a rare combination of scientific insight and enterprise-wide quality expertise,” said McLellan, emphasizing her pivotal role in the company’s strategic vision.

Sergio Gadaleta: Navigating Clinical and Regulatory Complexities

Sergio Gadaleta will take charge of leading QuidelOrtho’s global clinical trial strategies and regulatory submissions. He brings extensive experience from reputable companies such as BD, 3M, and Johnson & Johnson, plus a prestigious stint at the U.S. Food and Drug Administration (FDA). Gadaleta will be instrumental in engaging with regulatory bodies, ensuring that the company’s innovations successfully navigate complex global regulations.

“His 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 at QuidelOrtho. Gadaleta's leadership will guide the company's endeavors to enhance their clinical and regulatory pathways, making vital diagnostics more accessible to healthcare providers worldwide.

A Commitment to Operational Excellence

QuidelOrtho's strategic appointments are part of its ongoing efforts to boost productivity and efficiency within its R&D team. By reinforcing its leadership with talented individuals who possess a wealth of experience in their respective fields, QuidelOrtho aims to build a high-performance organization focused on scientific excellence, customer trust, and global reach.

The company believes that by investing in its quality and regulatory affairs departments, it can further enhance its product offerings, ensuring they meet the evolving demands of the healthcare market. With a dedication to advancing diagnostics, QuidelOrtho seeks to power healthier futures by providing rapid, accurate, and reliable diagnostic solutions.

“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,” the company stated.

Conclusion

In conclusion, the leadership appointments at QuidelOrtho mark a significant step toward solidifying its stature as a global leader in diagnostic technologies. The integration of Devon Burek and Sergio Gadaleta into the executive team will bolster operational efficiency, enhance product quality, and streamline clinical and regulatory processes, thereby positioning QuidelOrtho for continued success in the rapidly evolving diagnostics landscape.