Director, Global 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.

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The Director,Cell Therapy Global Operations Excellence 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 continuously develop and optimize AstraZeneca’s processes so as to support the successful delivery of Cell Therapy Programmes.

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

• Collaborate as part of the Study Management Functional Process Expert (SM FPE) network, 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 the needs and considerations relevant to CTCO Study Management and Program Management Teams.
• Liaise and cooperate closely with BPMO in Process Quality and Learning (PQL) alongside system owners within Global Clinical Solutions (GCS) to ensure Cell Therapy-specific user requirements are met in all AZ global systems and processes, and to support effective implementation across GSTs

Typical Accountabilities

• Works closely with BPMO and owners of any AZ systems used by CTCO GSTs 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 required procedural documents
• Process critical metrics & measurement: Developing, crafting and applying insights from process metrics to advise process and business improvement activities in their function
• Change agent to support the effective uptake and adoption of new and changed processes including directing comms and engagement effort in the functions to the right user communities
• 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 SM activities
• Being the first point of contact for the GST 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 GSTs 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 are

Education, Qualifications, Skills and Experience

Essential

• Bachelor of Science or equivalent experience in an appropriate subject

• 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
• 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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Are you interested in working at AZ, apply today!

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.