Director, Cell Therapy Quality Management

Director, Cell Therapy Quality Management

Resumen

Localización

Area

Tipo de contrato

Fecha de publicación

09-01-2026

Descripción de la oferta

Location Barcelona - Spain (3 days working from the office and 2 days working from home) Introduction 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. The Dir. CT QM role has a specific area of expertise within CTCO BPQL in the following manner: Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards. Deliver or drive the development of quality‑related initiatives and continuous improvement programmes that would support improved Quality and Compliance within CTCO trials and within CTCO‑related processes and initiatives. First line of Qulity support to all CTCO trials and CTCO‑related initiatives. To operate within established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality, Learning & Transformation (PQLT). Accountabilities CT BPM work 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 if needed to 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. Education, Qualifications, Skills and Experience Essential Bachelor of Science in an appropriate discipline or equivalent experience. 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 knowledge. Demonstrated time management acumen and proven skills to deliver responses and support. Experience in working successfully and collaboratively with both internal and external partners. Demonstrated strong written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge

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