Manager Clinical Quality and Compliance

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet The Team As a Manager Clinical Quality and Compliance you will be responsible for overseeing various aspects of quality management within the organization, with a focus on clinical operations. You will play a critical role in ensuring adherence to regulatory standards, maintaining high-quality standards, and fostering a culture of continuous improvement. You will collaborate cross-functionally with various departments to drive clinical quality initiatives and support the company's objectives. Where You Come In Quality First and Safety Management: Promote a culture of quality Manage clinical safety oversight Implement measures to ensure product quality and patient safety Champion continuous improvement initiatives Protocol Review Review and approve clinical study protocols Ensure protocols are in compliance with regulatory requirements and company standards Collaborate with cross-functional teams to optimize study designs PMCF (Post-Market Clinical Follow-up) Review Lead the review and management of post-market clinical follow-up activities. Ensure compliance with regulatory requirements and company standards Vendor Qualification Develop and implement vendor qualification processes Evaluate and qualify vendors according to established criteria Support vendor performance and adherence to quality standards Audit Lead/Support Lead or support internal and external audits as required Develop audit plans and schedules Coordinate audit responses and follow-up on corrective actions Procedure Development Develop and maintain quality procedures and work instructions Ensure procedures are aligned with regulatory requirements and best practices Train staff on quality procedures and ensure adherence CAPA (Corrective And Preventive Action) Management Lead the CAPA process, including investigation, root cause analysis, and implementation of corrective/preventive actions Monitor CAPA effectiveness and closure within established timelines Validation Review/Approval Review and approve validation protocols and reports Ensure validation activities are conducted in compliance with regulatory requirements and industry standards Cross-Functional Collaboration Collaborate with cross-functional teams to address quality-related issues and drive improvements. Act as a subject matter expert on quality matters and provide guidance to stakeholders ETMF (Electronic Trial Master File) Management Oversee the management of the electronic trial master file system Ensure eTMF completeness, accuracy, and compliance with regulatory requirements Document System Oversight Provide oversight of document management systems Ensure proper documentation practices and version control Implement improvements to streamline document processes What Makes You Successful Experience working in clinical research and knowledge of clinical trial design and analysis. Minimum of 3 year in Clinical Quality role Experience in audit support Excellent communication and presentation skill