Senior Manager, Quality Assurance & Regulatory Compliance

Medix Biochemica is a global leading company powering the in vitro diagnostics (IVD) industry with mission-critical raw materials. With Finnish roots and operations across Europe, the U.S., and Asia, our teams work at the intersection of science, manufacturing, service and reliability - helping our customers deliver trusted diagnostic results to billions of patients worldwide. What sets Medix Biochemica apart is not just what we do, but how we do it. We are an independent, science-driven partner focused on quality at scale, supply security, and sustainable technologies. Our global manufacturing footprint and local technical service teams enable us to move quickly, support customers close to where they operate, and build consistency into every product we deliver. Backed by strong financial resources and a clear long-term strategy, we’ve grown through targeted acquisitions and continued investment in people, capabilities, and infrastructure - all in service of our ambition to be the first-choice partner for mission-critical IVD components . This growth has expanded our portfolio and created new opportunities for collaboration, innovation, and impact across disciplines, and geographies. Just as we’re committed to enabling reliable diagnostics, we’re equally committed to creating a workplace where people can do meaningful work and grow. Our culture is guided by shared values - We Care, We Dare, and We Deliver - which shape how we work together, challenge ideas, and turn scientific expertise into real-world impact. With over 260 colleagues globally, Medix Biochemica offers the scale of an international organization with the openness, agility, and purpose of a company still building its future. Role description: The Senior Manager, Quality Assurance and Regulatory Compliance of St. Louis site provides strategic and operational leadership for Quality Assurance and applicable regulatory compliance at Medix Biochemica’s Ltd operations. The Senior Manager is responsible for the effectiveness, maintenance and continuous improvement of the local ISO 13485-based Quality Management System and for its alignment with Medix Biochemica’s global quality strategy, policies and ways of working. The Senior Manager manages applicable USDA and FDA registrations. The position acts as the local Quality Management Representative and is a key member of the Global Quality team and the site leadership organization. The Senior Manager works closely with Manufacturing, Operations, Supply Chain, R&D, Product Management, Quality Control and other Medix Biochemica functions. A central purpose of the role is to build a proactive quality culture in which Quality Assurance works as a close partner to Manufacturing. The Senior Manager promotes lean-thinking, operational discipline, structured problem-solving and continuous improvement while ensuring that product quality and regulatory compliance are maintained. Key task and responsibilities: Implement the global quality and sustainability strategy and objectives across site operations. Lead and develop the site Quality Assurance organization and sever as a member of Global Quality Team. Act as the local Quality Management Representative and report on QMS and sustainability performance, risks, resource needs and improvement priorities. Maintain and continuously improve the ISO 13485-compliant QMS, including document control, training, risk management, deviations, nonconformities, CAPA, change control, complaints, supplier quality and management review. Establish and monitor quality objectives, KPIs and improvement actions. Work as a close partner to manufacturing to improve process reliability, workplace organization, contamination control, standard work and operational discipline. Apply lean and other structured problem-solving methods as part of normal quality work to eliminate waste, simplify processes and improve performance without compromising compliance, product quality or tracea…

View the full posting and apply