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The Director, Cell Therapy Quality Management (Dir. CT QM) role will work in a collaborative manner with other members of the (CTCO) (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:
1. Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards.
2. 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.
3. First line of Quality support to all CTCO trials and CTCO-related initiatives.
4. To operate within established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality, Learning & Transformation (PQLT).
Typical Accountabilities
5. CT BPM works closely with the BPQL team, ensuring:
6. Insights related to CTCO-specific process-related issues requiring corrective actions are documented for potential future process improvements.
7. Process critical metrics & measurement: Support development, using quality-related data to inform process and business improvement activities.
8. Perform efficiency 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.
9. Call out, as needed, to 2nd Line Quality and the broader CTQN any issues or risks related to any CTCO-related studies or initiatives
10. Communicate on a routine basis, relevant quality-related insights and feedback to the greater CTCO organization
Education, Qualifications, Skills and Experience
Essential
11. Bachelor of Science in an appropriate field or equivalent experience
12. At least 7 years of relevant operational and/or quality experience in Drug Development within a pharmaceutical or clinical background
13. Solid understanding of business process, technology and Clinical Study information knowledge
14. Demonstrated time management foresight and proven skills to deliver responses and support
15. Experience in working successfully and collaboratively with both internal and external partners
16. Demonstrated strong written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills
17. Strong knowledge of Clinical Trials related international regulations, guidelines and standards (ICH GCP, FDA, EMA regulations and guidelines as minimum), as well as AZ internal standards and procedures, across functions
18. Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus
19. Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership and accountability
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .
Date Posted
03-Dez.-2025
Closing Date