Director, Cell Therapy Country Operations Excellence
Location: Warsaw
Hybrid Model: 3 days per week from office
The Director, Cell Therapy Country Operations Excellence (Dir. CT Country Ops Exc) role is a key intermediary between the Cell Therapy Clinical Operations (CTCO) Business Processes, Quality & Learning (BPQL) and Business Process Management & Optimisation (BPMO) by primarily representing the perspective and considerations for Local Study Teams (LSTs) involved in Cell Therapy studies.
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 that meet the needs and considerations relevant to involved Site Management & Monitoring (SMM) countries.
- Jointly responsible with 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 across LSTs
Typical Accountabilities
Dir. 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 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 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
Escalate 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 discipline 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
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, demonstrating a growth mindset, innovation, ownership and accountability
Desirable:
Previous experience 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