Parabilis Medicines

Manager

• Implementing and maintaining the company’s quality management system (QMS) to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH, etc.) and internal standards
• Manage the lifecycle of GxP documents to ensure compliance with regulations and internal procedures
• Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations
• Support all inspection readiness initiatives including but not limited to self-inspections and regulatory inspections
• Support the tracking and reporting of quality KPIs (e.g., deviation closure time, audit findings, etc.) and assist in the preparation of slides, meeting coordination and presentation of quality trends to senior leadership
• Support qualification and approval activities of external suppliers
• Manage training requirements, curricula and learner roles in the company Learning Management System (LMS)

Quality Systems Manager