Collaborate with the GMP QMS Lead to plan and manage changes linked to the process. * Perform the Quality System Monitoring Report used in the Management Review Process. * Serve as back-up to the GMP Corporate Complaints Management Process Owner (CPO). * Serve as subject matter expert for the Corporate Complaint process, updating procedural documentation and associated training. * Identifies and leads efficiency and improvement initiatives. * Expert knowledge of applicable regulations, quality principles, business processes, and techniques. * Minimum 10 years in pharmaceutical/biologics industry in Quality Assurance, including Biopharmaceuticals/Advanced Therapies. * In-depth understanding of Health Authority compliance expectations for reporting quality-related issues (GMP, Clinical). * Ability to lead investigations, identify root causes, and define CAPAs. * Jefferson Wells * Braine l'Alleud
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