Description

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.

Requirements

• •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

Tasks

• •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