Manufacturing Operations QA Senior Manager

- Leads the manufacturing site toward excellence in product quality, operational performance, and a culture of putting patients first.- Drives the integrated Quality and GOSC strategies to achieve results.- Engages with and influences leaders across multiple teams, including Core Quality, Operating Units (OUs), and GOSC.- Leads the QA function to ensure quality system development and compliance with FDA Quality System Regulation, ISO 13485/8, MDD, CMDR, and other applicable quality requirements.- Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services meet established internal and external standards and guidelines.- Leads audit and inspection preparation, manages the resolution of audit and inspection findings, and liaises with auditing groups and inspectors throughout all stages of the audit process.- Promotes global standardization and best practice sharing to support the company’s mission worldwide.- Develops, evaluates, implements, and maintains technical quality assurance and control systems or reliability systems and standards related to materials, techniques, and company products.- Leads strategic planning within the function to drive continuous improvement and effectiveness of Quality Operations and Quality Systems.- Coordinates activities with external suppliers and consultants to ensure timely delivery.- Serves as CAPA Board Chair to ensure the effectiveness of the CAPA process and to drive the development of systems and processes for identifying, analyzing, correcting, and preventing quality issues.- Acts as Management Representative to ensure the effectiveness and suitability of the Quality Management System.- Represents the Ho Chi Minh site in OU/Enterprise Quality Leaders team meetings; collaborates with peers across sites and Operating Units on global quality initiatives; and works closely with other MDT sites on shared quality concerns.