Job Description

Are you ready to play a pivotal role in advancing cell therapy programs? As the Associate Director of Cell Therapy Clinical Quality, you'll collaborate with the Cell Therapy Clinical Operations team to provide expert quality advice and coaching.


Your mission is to ensure the successful delivery of cell therapy programs by guiding the Site Management and Monitoring organization in maintaining high-quality standards. You'll be responsible for developing, tracking, and analyzing quality metrics at regional or country levels, applying GCP principles, and recommending improvements to enhance compliance.

Accountabilities

--------------------


In this dynamic role, you'll assess training compliance, facilitate resolution of compliance issues, and promote best practices within CT SMM countries. You'll be instrumental in fostering a quality culture, offering consultation during inspections and audits, and providing insights from quality metrics to improve performance. As a key member of regional leadership teams, you'll support quality review meetings, manage risk registers, and escalate issues when necessary. Your collaboration with the Director of Cell Therapy Quality Management will be crucial in driving continuous improvement initiatives.

Essential Skills/Experience

-------------------------------

Bachelor of Science in an appropriate discipline or equivalent experience At least 4 years of relevant operational and/or quality experience in Drug Development within a pharmaceutical or clinical background Good knowledge of business process, technology and Clinical Study information knowledge Demonstrated time management acumen and proven skills to deliver responses and support to internal and external stakeholders Experience in working successfully and collaboratively with both internal and external partners Demonstrated strong written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills 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 Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus Ability to manage multiple competing priorities, demonstrating a growth mindset, innovation, ownership and accountability

Desirable Skills/Experience

-------------------------------

Good reputation within the business and industry Good understanding and knowledge regarding Cell Therapy-relevant procedures Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement Experience in the development and management of Business Process to deliver business performance

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


At AstraZeneca, we fuse science and data to develop bold solutions that make a real difference. Our environment encourages seeking the best solutions and using data to drive scientific breakthroughs. We embrace challenges with a supportive yet inspiring approach that fosters learning. Here, dedication is key as we work on unknowns with courage and curiosity. Our collaborative mindset allows us to leverage diverse perspectives for maximum impact. With countless learning opportunities, AstraZeneca is rapidly growing and investing in technology. Join us to make a profound impact on society and patients worldwide.


Ready to make a difference? Apply now to join our team!