Director, Cell Therapy Global Operations Excellence
Director,Cell Therapy Global Operations Excellence
Location: Warsaw
Hybrid Model: 3 days per week from office
TheDirector,Cell Therapy Global Operations Excellence (Dir. CT Global OpsExc)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.
TheDir. CT Global OpsExc role will function within the BPQL team with a focused responsibility to meet the needs and considerations relevant to CTCO Study Management and Program Management Teams.
TheDir. CT Global OpsExc 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 numerousclinical process areas so asto 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 that meet the needs and considerations relevant to CTCO Study Management and Program Management Teams.
- Jointly responsible with the BPMO for the successful implementation of a process-centric culture to improve quality & efficiency and to support delivery of changes and improvements to the business processes and procedures which underpin clinical trials.
- 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 acrossGSTs
Typical Accountabilities
Dir. CT Global OpsExcworks closely with BPMOand owners of any AZ systems used by CTCO GSTsmaintainingglobal 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 KPIs & measurement: Developing, designing and applying insights from process metrics to inform 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 best practice 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
Escalate to the BPMO,any issues or risks that cannot be resolved at the functional level
Responsible for lifecycle management of relevant procedural documentsguidelines, 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 documentsthat impactGSTs and available, wherever reasonable, for internal and external inspections, audits and follow-up related to Cell Therapy-specific functional process questions
Beingthe 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 discipline or equivalent experience
At least 7 yearsof 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
Ability to effectively influence and communicate; ability to engage and collaborate across boundaries with problem solving focus
Ability to drive and champion global change and actively advocate and implement more efficient and effective processes
Ability to manage multiple competing priorities, demonstratinga growth mindset, innovation, ownership and accountability
Desirable:
Previousexperience in Process Owner’s roles
Previous experience in attending regulatory inspections
Expert reputation within the business and industry
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
What we offer:
Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.
To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:
- The best team to support you,
- Multisport card,
- Pension plan,
- Life insurance,
- after-work events,
- private medical care
- lunch card,
- bright and spacious environment,
- sustainable office working environment.
Please note that we are working in a hybrid model of 3 days per week from the office in Warsaw
Date Posted
28-sie-2025Closing Date
08-wrz-2025AstraZeneca 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.
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