Lori Smith-Sakalousky serves as the Vice President of Global Operations at RQM+, where she plays a pivotal role in shaping the company’s operational framework and driving international growth. With over a decade of experience in the regulatory and quality consulting industry, Lori leads a diverse...
Lori Smith-Sakalousky serves as the Vice President of Global Operations at RQM+, where she plays a pivotal role in shaping the company’s operational framework and driving international growth. With over a decade of experience in the regulatory and quality consulting industry, Lori leads a diverse team of 150 professionals, including regulatory and quality engineers, program managers, and a dedicated design and delivery team. Under her leadership, RQM+ has established a robust operations infrastructure that not only enhances employee leadership and development but also optimizes resource allocation to ensure the delivery of high-quality services.
Lori's commitment to client satisfaction is evident in her team's impressive average rating of 9+ from clients, a testament to their dedication to excellence in service delivery. Her expertise in regulatory compliance, particularly with ISO 13485 and U.S. Food and Drug Administration (FDA) standards, positions RQM+ as a trusted partner in the medical device and life sciences sectors. Key projects under her guidance have focused on implementing effective Corrective and Preventive Action (CAPA) strategies, validation processes, and comprehensive business development initiatives that align with industry best practices.
In addition to her operational responsibilities, Lori is passionate about fostering a culture of continuous improvement and innovation within her team. By leveraging her extensive knowledge in engineering and management, she ensures that RQM+ remains at the forefront of the industry, helping clients bring safe and effective products to market while navigating the complexities of regulatory landscapes. Her leadership not only drives operational success but also cultivates an environment where employees are empowered to excel and contribute to the company’s mission.
