At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

The Director, Cell Therapy Quality Management (Dir. CT QM) role will work in a collaborative manner with other members of the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (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.

Deine Aufgaben

The Dir. CT QM role has a specific area of expertise within CTCO BPQL in the following manner:

• Work closely with CTCO Process Owners in order to ensure that any established processes adhere to AZ global quality standards.
• 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.
• First line of Quality support to all CTCO trials and CTCO-related initiatives.
• To operate within established AstraZeneca Quality group, including but not limited to the Cell Therapy Quality Network (CTQN), and Process Quality, Learning & Transformation (PQLT).

Dein Profil

Typical Accountabilities

• CT BPM works closely with the BPQL team, ensuring:
• Insights related to CTCO-specific process-related issues requiring corrective actions are documented for potential future process improvements.
• Process critical metrics & measurement: Support development, using quality-related data to inform process and business improvement activities.
• 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.
• Call out, as needed, to 2nd Line Quality and the broader CTQN any issues or risks related to any CTCO-related studies or initiatives
• Communicate on a routine basis, relevant quality-related insights and feedback to the greater CTCO organization

Was wir bieten

Education, Qualifications, Skills and Experience

Essential

• Bachelor of Science in an appropriate field or equivalent experience
• At least 7 years of relevant operational and/or quality experience in Drug Development within a pharmaceutical or clinical background
• Solid understanding of business process, technology and Clinical Study information knowledge
• Demonstrated time management foresight and proven skills to deliver responses and support
• 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