Beschreibung

In this role, you will collaborate with the Cell Therapy Clinical Operations team to provide quality guidance and ensure trials meet global standards. Your day-to-day responsibilities will involve driving quality initiatives, supporting audits, and sharing insights to enhance compliance and process improvements.

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

Aufgaben

• •Collaborate with the Cell Therapy Clinical Operations team
• •Provide expert quality advice and coaching
• •Ensure CTCO trials are ready for audits and inspections
• •Work with Process Owners to maintain adherence to global quality standards
• •Drive the development of quality initiatives and continuous improvement programs
• •Serve as the first line of Quality support for CTCO trials
• •Operate within the AstraZeneca Quality group and related networks
• •Document insights on process-related issues for future improvements
• •Support the development of process critical metrics and measurements
• •Perform efficiency checks to support remediation of study-related CAPAs
• •Communicate quality-related insights and feedback to the CTCO organization