Clinical Quality Operations, Oncology III

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fw6z

Overview Qualsiasi informazione aggiuntiva su questo lavoro è disponibile nel testo sottostante. Si assicuri di leggere attentamente, quindi invii la sua candidatura. Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. By conducting clinical trials and surveillance, we ensure the safety and efficacy of existing and pipeline products, producing safe, effective, innovative medicine. Responsibilities The Clinical Quality Operations Manager (CQOM) is responsible for: Leading the strategic implementation of 'quality by design' principles in assigned clinical trials. Developing risk assessment and categorization tools and quality plans in partnership with the Clinical Trial Team. Periodically reviewing therapy‐area level quality plans and risk mitigation approaches, providing feedback to leadership. Facilitating and overseeing responses to audit and inspection observations. Analyzing data across therapy areas to identify signals and trends and implementing process improvement strategies.



Staying current on Good Clinical Practice and digital data management technology, maintaining profound knowledge of GCP with respect to digital data management. Building effective working relationships with key stakeholders, ensuring role clarity and business effectiveness. Ensuring comprehensive oversight of all activities delegated to third parties. Maintaining regulatory inspection readiness, preparing for inspections, and managing follow‐up actions. Monitoring and communicating regulatory developments within the CQO organization. Coordinating cross‐functional teams (Quality & Continuous Improvement, GCTO Country Operations, PV, GRACS, IT, etc.) to support regulatory inspections worldwide. Maintaining the global inspection tracking system, auditing findings, responses, and CAPAs. Tracking and verifying completion of CAPA and regulatory commitments related to audits and inspections. Providing guidance to Clinical Q

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78fw6z