Director, Cell Therapy Quality Management
Location: Barcelona - Spain (3 days working from the office and 2 days working from home)
Introduction
TheDirector,Cell TherapyQualityManagement(Dir. CT QM)rolewill work in a collaborative manner with other members of theCell Therapy Clinical Operations(CTCO)Business Processes, Quality & Learning(BPQL)teamin ordertoprovide expert quality advice and coachingso as to support the successful delivery of Cell Therapy Programmes.
TheDir. CT QMrole will functionto supporttheteams across CTCOin order toensure that all CTCO trials areprepared forbothinternal and external auditsand inspections.
TheDir. CT QMrole has a specific area of expertise within CTCO BPQL in the following manner:
Work closelywith CTCO Process Ownersin order toensure that any established processes adhereto AZ global quality standards.
Deliver or drive the developmentofquality-relatedinitiatives andcontinuousimprovement programmesthat would support improved Quality andCompliancewithinCTCO trialsand within CTCO-related processes and initiatives.
FirstlineofQuality support toallCTCO trialsand CTCO-related initiatives.
Tooperatewithin established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality,Learning & Transformation(PQLT).
Accountabilities
CT BPMworkscloselywith the BPQL team,ensuring:
- Insights related to CTCO-specificprocess-relatedissues requiring corrective actions are documented for potential future process improvements.
- Process KPIs & measurement:Support development,using quality-related datatoinform process and business improvement activities.
- Performeffectiveness checks as neededtosupport the remediation of study-related CAPAs and if needed toverify theuptake and adoption of new and changedCTCO-relatedprocesses.
Escalate, as needed,to2ndLine Quality and the broader CTQNany issues or risksrelated to anyCTCO-related studies or initiatives
Communicate on a routine basis, relevant quality-relatedinsightsand feedback to the greater CTCO organization
Education, Qualifications,Skillsand Experience
Essential
Bachelor of Science inan appropriate disciplineor equivalent experience
At least7yearsofrelevantoperationaland/or qualityexperience in Drug Development within a pharmaceutical or clinical background
Strong knowledgeof business process, technology and ClinicalStudy information knowledge
Demonstratedtimemanagementacumenand proven skills to deliverresponses andsuppor
Experience in working successfully and collaboratively withboth internal andexternal partners
Demonstratedstrongwritten and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflictmanagementand interpersonal skills
Strongknowledge of Clinical Trials related international regulations,guidelinesand standards(ICH GCP, FDA, EMAregulationsand guidelines as minimum), as well as AZ internal standards and procedures, across functions
Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus
Ability to manage multiple competing priorities,demonstratinga growth mindset,innovation,ownershipand accountability
Desirable
Strongreputationwithin the business and industry
Strong understanding and knowledgeregardingCell Therapy-relevant procedures
Experience ofutilizingstandard process improvement methodologies (e.g. Lean Six Sigma) toidentifyroot causes of process issues andidentifyareas of process improvement
Experience in the development and management of Business Process to deliver business performance
Date Posted
04-dic-2025Closing Date
09-ene-2026AstraZeneca 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. 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.
AstraZeneca 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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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