AstraZeneca
BioPharmaceuticals
AssociateDirector,SystemOwner
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Director, System Owner at AstraZeneca. Skills: System Owner, Lifecycle management, Continuous improvement. Leadership, lifecycle management and continuous improvement of Clinical Systems. Identification, definition and delivery of improvements”
Industry & Context.
Removes barriers, supplies solutions and finds opportunities for improvement
What They're Looking For.
Must Have
Bachelor of Science (BSc) in a life science or computer science, or equivalent experience, Deep understanding of the drug development process, including clinical development, High level of business process, technology and Clinical Study information knowledge, Extensive experience working with computerized systems in a regulated environment (e.g. GxP), Experience working successfully and collaboratively with external partners delivering mutual benefit, Proven ability to deliver to time, cost and quality, Demonstrated excellent written and verbal communication skills
Nice to Have
Experience in tech industry, Experience of using standard process improvement methodologies (e. g. Lean Six Sigma), Comprehensive knowledge of ICH/GCP, Recognised AGILE certification (e. g. SAFe), Experience of Quality Systems and Quality Management, Project Management certification, Project Management software experience (e. g. Jira) familiarity, Service Management experience, Experience working with Artificial Intelligence implementation
What You'll Do.
lifecycle management and continuous improvement of Clinical Systems
definition and delivery of improvements
Utilising tools and techniques for continuous improvement
Ensuring system meets ICH/GxP requirements
Aligns with industry direction
Represent business interests in strategy discussions
Provides strategic advice to Governance team
Reviews and approves identified system risks and mitigations
Controls and prioritizes all business requests
Accountable for communication to key stakeholders
Lead and manage improvement projects
Contribute to functional
regional and global initiatives
continuous improvement
Ongoing customer support for allocated systems
Lifecycle management of procedural or system documents
Ensuring compliance with industry regulations
Plans and prioritizes product feature backlog
Defines system vision
road-map and growth opportunities
Researches and analyses business context
Partner with and provide leadership to service delivery teams
Engage and influence internal and external key stakeholders
Ensure customer requirements are understood
Monitor performance of assigned system
track and monitor key performance indicators
Inform improvement plans
Support audit and regulatory inspection planning
Understands processes
technology and services
Supplies advice and guidance
Finds opportunities for improvement
Supplies guidance and expertise in planning
Delivery of system validation activities
Production and archiving of validation documentation
How You'll Work.
Team & Collaboration
Works closely with vendors, R&D IT, Functional Process Owners, BPMO, internal and external customers and stakeholders; Experience working successfully and collaboratively with external partners; Partner with and provide leadership to service delivery teams; Engage and influence internal and external key stakeholders
Communication Scope
Demonstrated excellent written and verbal communication skills
Process & Methodology
Project Management certification, Project Management software experience
Full Job Description
**Introduction to role:** Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation, owning and providing industry leading technology and services on behalf of Clinical Operations and its internal and external Partnerships. System Owner is a member of Global Clinical Solutions Technologies (GCS Tech) department and is end-to-end accountable for the leadership, lifecycle management and continuous improvement of Clinical Systems. System Owner works closely with vendors, R&D IT (Information Technology), Functional Process Owners, Business Process Management Office (BPMO), internal and external customers and stakeholders to ensure customer needs are met and to enable optimal end-to-end delivery of clinical studies. System Owner is responsible for the identification, definition and delivery of improvements in end-to-end clinical study delivery, utilising tools and techniques to achieve continuous improvement and value creation (i.e. Lean Six Sigma). System Owner ensures that the System meets ICH/GxP requirements and aligns with industry direction, standards, and best practices. The System Owner represents the business interests in strategy discussions and provides strategic advice to the Governance team in securing long-term business success of their assigned systems. Reviews and approves identified system risks and mitigations. Controls and prioritizes all business requests, such as those for feature enhancements, ensuring prioritization so resources (staff, vendor budget) are spent on value-add activities. Accountable for communication to key stakeholders and the business regarding the system (major incidents, new releases, etc.). System Owner will lead and manage improvement projects as needed, and will contribute to functional, regional and global initiatives. **Accountabilities:** * Design, development, implementation, maintenance, continuous improvement and ongoing customer support for the
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