AstraZeneca
Director, Cell Therapy Quality Management(m/w/x)
Vollzeit
Senior
Keine Angabe
Hamburg
AS
AstraZeneca Canada Inc.1 Monat
Director, Cell Therapy Quality Management(m/w/x)
Management
Vollzeit
Keine Angabe
Hamburg
Nejo KI-Zusammenfassung
In this role, you will work closely with the Cell Therapy Clinical Operations team to ensure quality compliance across trials. Your day-to-day responsibilities will involve driving quality initiatives, providing support, and communicating insights to enhance process efficiency and compliance.
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Anforderungen
- •Bachelor of Science in an appropriate field or equivalent experience
- •At least 7 years of relevant operational and/or quality experience in Drug Development
- •Solid understanding of business process and technology
- •Demonstrated time management foresight and proven skills to deliver responses and support
- •Experience in working successfully and collaboratively with internal and external partners
- •Demonstrated strong written and verbal communication and influencing skills
- •Strong knowledge of Clinical Trials related international regulations and guidelines
- •Ability to effectively influence and communicate
- •Ability to manage multiple competing priorities
Bachelor-Abschluss
Berufserfahrung
7 Jahre
Deine Aufgaben
- •Collaborate with CTCO Process Owners to ensure adherence to AZ global quality standards
- •Drive the development of quality-related initiatives and continuous improvement programs
- •Provide first-line quality support for all CTCO trials and initiatives
- •Document insights on CTCO-specific process-related issues for future improvements
- •Support the development of process critical metrics using quality-related data
- •Perform efficiency checks to support remediation of study-related CAPAs
- •Verify the adoption of new and changed CTCO-related processes
- •Communicate quality-related insights and feedback to the CTCO organization
- •Identify and escalate issues or risks related to CTCO studies to 2nd Line Quality and CTQN
Sprachen
Englisch – verhandlungssicher
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