Director, Cell Therapy Quality Management

Director, Cell Therapy Quality ManagementUsted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura.Location:Barcelona - Spain (3 days working from the office and 2 days working from home)6 days ago Be among the first 25 applicantsIntroductionTheDirector, 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.SpecializationWork 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).AccountabilitiesCT 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 ExperienceBachelor 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 transfer (mentoring), conflict management and interpersonal skills.Strong knowledge of clinical trials related international regulations, guidelines and standards (ICH GCP, FDA, EMA, etc.) and AZ internal standards and procedures across functions.Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with a problem‑solving focus.Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership and accountability.DesirableStrong reputation within the business and industry.Strong understanding and knowledge regarding cell‑therapy‑relevant procedures.Experience utilizing standard process improvement methodologies (e.g., Lean Six Sigma) to identify root causes of process issues and areas of improvement.Experience in developing and managing business processes to deliver business performance.Posting InformationDate Posted:04-dic-2025Closing Date:09-ene-2026Job DetailsSeniority level: DirectorEmployment type: Full‑timeJob function: Quality AssuranceIndustry: Pharmaceutical ManufacturingAstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. xsgfvud We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.#J-18808-Ljbffr