| We're looking for a Quality Professional to help us accomplish our mission to improve lives by learning from the experience of every cancer patient. Here's what you need to know about the role, our team, and why Flatiron Health is the right next step in your career. What You'll Do In this role, you'll work with the Integrated Quality Management team and cross-functional research teams to define, maintain, oversee, and optimize the quality management system. You will provide quality partnership across Flatiron Health’s business through quality management and quality oversight activities intended to accelerate quality improvement. This includes support for our research initiatives and the associated software development lifecycle (e.g., risk-based validation). Such support includes collaborating with key stakeholders to provide guidance on quality matters and lead the implementation of key elements of the quality program against strategic priorities. In addition, you'll also: - Provide proactive quality support regarding research best practices, document management (including quality assurance [QA] and quality control [QC] checks), process development/improvement, and risk management
- Implement risk-based computer systems validation activities focused on risk assessment, identification, escalation, and management
- Issue management and corrective/preventive action (CAPA) management
- Ensure proactive audits/inspection readiness. Support external audits/inspections, including liaising with clients, hosting on-site visits, and internal oversight of associated action plans
- Enhance, implement, and assess the health of Flatiron’s quality management system
- Foster a quality culture focused on meeting high quality, ethical and regulatory standards
- Design, implement, and oversee quality training
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