Manage GMP quality assurance oversight of manufacturing, testing, and supply chain activities for assigned products.
Review and approve batch records, deviations, CAPAs, and change controls; lead or support internal and external GMP audits.
Manage quality agreements with external manufacturing partners and represent Quality during health authority inspections.
Beeline Medicines is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. The company is backed by world-class life science investors and led by an established executive team.
Serve as Global Process Owner for CAPA subsystem, ensuring compliance with FDA, ISO, and EU MDR requirements.
Lead complex investigations using root cause analysis tools and mentor cross-functional teams on best practices.
Monitor CAPA performance through KPIs, facilitate CAPA Review Board, and drive systemic improvements.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac tests. The company is publicly traded, has been used for over 500,000 patients worldwide, and is supported by international medical societies.
Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews.
Execute the yearly corporate audit plan, tracking audits and preparing detailed outcome reports for management.
Provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
Care Access is a clinical research company that brings world-class research and health services directly to communities. With hundreds of research locations and clinicians globally, they are dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.