QuidelOrtho Strengthens Leadership Team With Appointments of Senior Vice Presidents for Global Quality and Clinical & Regulatory Affairs
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.
QuidelOrtho (NASDAQ: QDEL), fornitore globale di diagnostica in vitro, ha rafforzato il proprio team dirigenziale con due nomine chiave. Devon Burek entra come Senior Vice President della Qualità Globale, portando oltre 20 anni di esperienza maturata in Roche, mentre Sergio Gadaleta assume il ruolo di Senior Vice President delle Affari Clinici e Regolatori, sfruttando la sua esperienza in BD, 3M, Johnson & Johnson e FDA.
Burek si concentrerà sull’ottimizzazione delle strategie globali di qualità e sul miglioramento dell’efficienza operativa. Gadaleta, che è in possesso di un dottorato in chimica, guiderà la strategia globale dell’azienda per gli studi clinici e le sottomissioni regolatorie, collaborando strettamente con la FDA e le agenzie sanitarie internazionali.
QuidelOrtho (NASDAQ: QDEL), proveedor global de diagnóstico in vitro, ha fortalecido su equipo directivo con dos nombramientos clave. Devon Burek se une como Vicepresidente Senior de Calidad Global, aportando más de 20 años de experiencia en Roche, mientras que Sergio Gadaleta asume el cargo de Vicepresidente Senior de Asuntos Clínicos y Regulatorios, aprovechando su experiencia en BD, 3M, Johnson & Johnson y la FDA.
Burek se enfocará en optimizar los enfoques globales de calidad y mejorar la eficacia operativa. Gadaleta, quien posee un doctorado en química, liderará la estrategia global de ensayos clínicos y las presentaciones regulatorias de la empresa, colaborando estrechamente con la FDA y agencias sanitarias internacionales.
QuidelOrtho (NASDAQ: QDEL)는 글로벌 체외 진단 제공업체로서 두 명의 핵심 임원 임명을 통해 리더십 팀을 강화했습니다. Devon Burek는 Roche에서 20년 이상의 경험을 바탕으로 글로벌 품질 담당 수석 부사장으로 합류했으며, Sergio Gadaleta는 BD, 3M, Johnson & Johnson, FDA에서의 경력을 활용하여 임상 및 규제 업무 담당 수석 부사장이 되었습니다.
Burek는 글로벌 품질 접근 방식을 간소화하고 운영 효율성을 향상하는 데 주력할 예정입니다. 화학 박사 학위 소지자인 Gadaleta는 회사의 글로벌 임상 시험 전략과 규제 제출을 이끌며 FDA 및 전 세계 보건 기관과 긴밀히 협력할 것입니다.
QuidelOrtho (NASDAQ: QDEL), fournisseur mondial de diagnostics in vitro, a renforcé son équipe de direction avec deux nominations clés. Devon Burek rejoint l’entreprise en tant que Vice-Président Senior de la Qualité Globale, apportant plus de 20 ans d’expérience chez Roche, tandis que Sergio Gadaleta devient Vice-Président Senior des Affaires Cliniques et Réglementaires, mettant à profit son expérience chez BD, 3M, Johnson & Johnson et la FDA.
Burek se concentrera sur l’optimisation des approches qualité mondiales et l’amélioration de l’efficacité opérationnelle. Gadaleta, titulaire d’un doctorat en chimie, dirigera la stratégie mondiale des essais cliniques et des soumissions réglementaires de l’entreprise, en collaboration étroite avec la FDA et les agences sanitaires internationales.
QuidelOrtho (NASDAQ: QDEL), ein globaler Anbieter von In-vitro-Diagnostik, hat sein Führungsteam mit zwei wichtigen Ernennungen verstärkt. Devon Burek tritt als Senior Vice President für Globale Qualität bei und bringt über 20 Jahre Erfahrung von Roche mit, während Sergio Gadaleta als Senior Vice President für Klinische und Regulatorische Angelegenheiten fungiert und seine Erfahrung von BD, 3M, Johnson & Johnson und der FDA einbringt.
Burek wird sich auf die Optimierung globaler Qualitätsansätze und die Steigerung der operativen Effizienz konzentrieren. Gadaleta, der einen Doktortitel in Chemie besitzt, wird die globale Strategie des Unternehmens für klinische Studien und regulatorische Einreichungen leiten und eng mit der FDA sowie internationalen Gesundheitsbehörden zusammenarbeiten.
- 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
- None.
New executives bring deep expertise to elevate quality and accelerate innovation across global operations
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
"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
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