Director, Country Operations Excellence - (Cell Therapy)

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 Dir. CT Global Ops Exc role will function within the BPQL team with a focused responsibility to meet the needs and considerations relevant to involved Site Management & Monitoring (SMM) countries and Local Study Teams (LSTs).

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

• Collaborate with relevant Site Management & Monitoring (SMM) Functional Process Experts (FPEs), and to be highly knowledgeable across numerous clinical process areas so as to have a unified global AZ process as is reasonably possible.
• Jointly responsible with CTCO BPQL and BPMO for the successful implementation of Cell Therapy-specific processes that meet (SMM) countries.

Typical Accountabilities

• Director, CT Country Ops Exc works closely with BPMO and owners of any AZ systems used by CTCO LSTs maintaining global process and tools and ensuring:
• Functional representation during development of process changes and improvements: providing functional inputs and leadership throughout the cycle of business process and procedural document changes
• Approving changes: Reviewing and managing the functional approval of all changes to clinical business processes and mandatory procedural documents
• Process critical metrics & measurement: Developing, crafting and applying insights from process metrics to advise process and business improvement activities in their function
• First line of support for process users: supporting functional process users by answering questions arising from the user community
• Being the functional subject matter expert and maintaining industry standard methodology awareness and up to date knowledge of international standards, regulations and guidelines relevant for LST activities
• Being the first point of contact for the LST process users regarding any questions, queries (including R&D Process Portal Helpdesk tickets), issues or risks that arise at the process functional level and provide business knowledge and guidance to the function
• Advance to the BPMO, any issues or risks that cannot be resolved at the functional level
• Responsible for lifecycle management of relevant procedural documents guidelines, forms, non-mandatory templates and training materials and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
• Inspection accountability for Cell Therapy-specific procedural documents that impact LSTs and available, wherever reasonable, for internal and external inspections, audits and follow-up related to Cell Therapy-specific functional process questions
• Being the champion of the process and any relevant SOPs and working practices at the functional level
• Responsible for the effective and timely communication of information, and to support the development and delivery of high-quality training materials for the allocated area
  

Education, Qualifications, Skills and Experience

Essential

• Bachelor of Science in an appropriate subject area or equivalent experience
• At least 7 years of extensive operational experience in Drug Development within a pharmaceutical or clinical background
• High level of business process, technology and Clinical Study information knowledge
• Demonstrated project management skills and proven skills to deliver to time and quality
• Experience in working successfully and collaboratively with external partners
• Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills
• Expert 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

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.