Sr. Director, Cell Therapy Business Processes, Compliance & Learning

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.

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Job Description

The Sr. Director, Cell Therapy Business Processes, Compliance and Learning (Sr.Dir CT BPCL) is accountable for developing, evaluating, improving and optimizing Clinical Operations clinical research processes, Compliance and learning required to deliver Cell Therapy clinical trials at AstraZeneca. The role will work to support successful execution of cell therapy studies while meeting internal and external standards and regulations. The role will collaborate with cross-functional teams to identify process improvement opportunities. The role will also support training and learning for cell therapy clinical team members. The role will be first line support for Compliance within CTCO.

Typical Accountabilities

• Accountable for ensuring that the AZ processes and procedures needed to support successful delivery of Cell Therapy Programmes support the requirements for Cell Therapies.
• Provide expert cell therapy clinical operational input into SOPs, Process and Template documents as they are updated
• Act as a functional expert to engage with other functions in developing their Cell Therapy Processes (for example Alliance Management)
• Perform gap analysis of new AZ processes and procedures relative to cell therapy requirements
• Author cell therapy-based processes and procedures as needed
• Support development of CTCO job descriptions and ensure harmonization across job descriptions within each function
• Identify areas of standard methodology / process improvements and knowledge share across the Cell Therapy Clinical Group and Cell Therapy Development Team.
• Contribute to transition plans and gap analysis needed for any corporate business acquisitions impacting cell therapy study delivery
• Contribute to review of new/amended/unique SOPs and guidance documents.
• Key interface between CTCO, Business Process Management Organization (BPMO) and operates across the clinical process area, to support high quality interactions on behalf of process users into the central business process management team.
• Accountable for ensuring Functional Process Experts are assigned from CTCO to support process and SOP development.

Compliance

• First line support for CTCO team for quality compliance, including Audits and inspections - engaging with wider Quality functions within ORD to enable effective responses and support for CTCO Study and Project teams.
• Accountable for Compliance critical metrics across CTCO, supporting Study Teams and Site Management and Monitoring in identifying early trends in quality compliance.
• Responsible for program level reporting of progress, risks, and issues associated with cell therapy processes, training and learning
• Maintaining industry standard process awareness and up to date knowledge of international standards, regulations and guidelines relevant for CTCO activities
• Inspection accountability for Study Management non-mandatory procedural documents and availability for inspection Q&A related to SM functional question

Learning and Training

• Develop overall Learning and Training strategy for CTCO, engaging with Learning Technology and Development functions across ORD to ensure robust training and learning plan is available to enable for CTCO teams to deliver studies in a compliance and efficient way.
• Develop and maintain central repository for Training and processes ensuring access to all members of CTCO and that all materials are available and accessible to teams.

Be a member of the Cell Therapy Clinical Operations Leadership Team, and as such:

• Sponsor Cell Therapy Clinical Operations non-drug strategy & organizational infrastructures
• Contribute to the development and maintenance of delivery models provided by Cell Therapy Clinical Operations, balancing partners needs and efficiency
• Deliver agreed activities within functional budget target including management of FTEs
• A catalyst for cross-functional improvements and driving organizational change
• Mentor and support development of individuals within the organisation

Education, Qualifications, Skills and Experience

Essential:

• Bachelor's of Science in an appropriate subject area
• Extensive experience in Study Management within a pharmaceutical or clinical background
• Previous experience in Business Process, learning and Compliance
• Thorough knowledge of Study Management processes and compliance
• 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
• 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
• Ability to drive and champion global change and actively advocate and implement more efficient and effective processes
• Excellent communication and relationship building skills

Desirable

• Advanced degree in a scientific subject area
• Expert reputation within the business and industry
• Experience of applying standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Extensive knowledge of the latest technical and regulatory expectations

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• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada's Most Admired Corporate Culture
• Learn more about working with us in Canada
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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
16-Apr-2025

Closing Date
15-May-2025

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.