Quality Partner Commercial (JAPAC)

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

This role operates across all Quality disciplines including but not limited to Quality Operations, Product Care & Technical Quality, Product Health & Monitoring and Quality Systems Excellence. Through engagement with the Quality Lifecycle teams will strengthen scientific and operational rigor, ensure sustainable compliance with applicable local regulations, leading and participating in initiatives to drive harmonization of processes and practices across the Global Quality Organization.  

The Commercial Quality Partner will collaborate with Regional Commercial Leadership, Business Unit Product Management, Regional Supply Chain and Regulatory Affairs to advance Quality excellence, accelerate innovation, and to build and maintain confidence in product and process quality.  

As a key member of the Global Quality & Compliance organization, this individual acts as a catalyst for continuous improvement, leveraging analytics, process excellence, and cross-functional collaboration. They will ensure that standardized global quality system processes will meet the needs of the region to maintain the highest level of compliance and product quality to enable customer and business outcomes.  

Key Responsibilities 

• Serves as the regional subject matter expert, within Global Quality & Compliance, providing technical and quality leadership, representing the Quality Function within the Commercial Leadership Team. Serves as a first point of contact for Quality issues identified within the Regional Commercial Team.  

• Collaborates cross-functionally to ensure Quality requirements are integrated throughout the product lifecycle, from design to commercialization and post-market to address issues impacting the Regional Commercial Team.  

• Uses data and analytics to monitor Quality system performance, identify risks and opportunities for the Regional Commercial Team. Recommend improvements based on trend analysis / voice of the customer.  

• Engages with the Quality Life Cycle teams, championing the voice of the customer, ensuring that Quality processes and decisions support patient safety, regulatory compliance, and business continuity influencing prioritization across the business to address quality & compliance issues to drive business and customer value.  

• Educates and provides guidance to Commercial Teams on Quality System requirements and regulations as needed (pertinent to their roles)​. Advises and enables Commercial Teams in the management of quality issues with customers and third-party partnerships.  

• Provides Quality support for the sales process, including coordination of Tender Support, completion of customer questionnaires and as necessary customer visits.  

• Ensure Quality systems, products, processes, and tools comply with global and regional regulatory requirements, including but not limited to China NMPA (National Medical Products Association), Japan PMDA (Pharmaceutical, Medical, Device Act), Korean GMP (K-GMP) Regulations.  

• Partners with other functional Quality teams, to deploy global procedures, tools, metrics, and process excellence initiatives, ensuring standardization of Quality processes and documentation across the region to improve compliance, efficiency, and integration across the region.   

• Supports inspection readiness and regulatory engagement, contributing technical expertise and ensuring sustainable compliance. Identifies and assesses quality risks within the region and works to implement mitigation strategies in collaboration with the Global Quality Team​.  

• Models QuidelOrtho’s leadership behaviors and culture, driving engagement, collaboration, and shared accountability for Quality outcomes. Fosters and promotes a culture of quality and continuous improvement across the region.   

• Provides guidance, coaching and mentorship to more junior Quality professionals, fostering scientific integrity, quality and compliance management, and a continuous improvement mindset.