Director, Cell Therapy Quality Management

hace 2 semanas


Barcelona, España AstraZeneca A tiempo completo

Director, Cell Therapy Quality Management Location: Barcelona - Spain (3 days working from the office and 2 days working from home) 6 days ago Be among the first 25 applicants Introduction The Director, Cell Therapy Quality Management (Dir. CT QM) role will work in a collaborative manner with other members of the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) team in order to provide expert quality advice and coaching so as to support the successful delivery of Cell Therapy Programmes. The Dir. CT QM role will function to support the teams across CTCO in order to ensure that all CTCO trials are prepared for both internal and external audits and inspections. Specialization Work closely with CTCO Process Owners to ensure that any established processes adhere to AstraZeneca global quality standards. Deliver or drive the development of quality‑related initiatives and continuous improvement programmes that support improved quality and compliance within CTCO trials and related processes. First line of quality support to all CTCO trials and CTCO‑related initiatives. Operate within established AstraZeneca Quality group, including the Cell Therapy Quality Network (CTQN) and Process Quality, Learning & Transformation (PQLT). Accountabilities CT BPM works closely with the BPQL team, ensuring: Insights related to CTCO‑specific process‑related issues requiring corrective actions are documented for potential future process improvements. Process KPIs & measurement: support development, using quality‑related data to inform process and business improvement activities. Perform effectiveness checks as needed to support the remediation of study‑related CAPAs and verify the uptake and adoption of new and changed CTCO‑related processes. Escalate, as needed, to 2nd Line Quality and the broader CTQN any issues or risks related to any CTCO‑related studies or initiatives. Communicate on a routine basis, relevant quality‑related insights and feedback to the greater CTCO organization. Essential Education, Qualifications, Skills and Experience Bachelor of Science in an appropriate discipline or equivalent experience. At least 7 years of relevant operational and/or quality experience in drug development within a pharmaceutical or clinical background. Strong knowledge of business process, technology and clinical study information. Demonstrated time‑management acumen and proven skills to deliver responses and support. Experience in working successfully and collaboratively with both internal and external partners. Strong written and verbal communication, influencing, negotiation, collaboration, problem‑solving, presentation, knowledge



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