AstraZeneca
ITQualityManager
Neural analysis suggests this role is
optimal for Manager candidates.
“IT Quality Manager at AstraZeneca. Skills: Quality Management, Compliance governance, Regulatory support. Assure projects meet regulatory requirements. Assure systems meet regulatory requirements”
What You'll Achieve.
Increase compliance levels; Increase quality levels
Industry & Context.
Risk assessment; Issue resolution
What They're Looking For.
Must Have
3-5 years of experience in pharmaceutical industry, Experience providing regulatory support, Experience with validation of laboratory applications, Experience with validation of business applications, Experience contributing to Quality strategy implementation, Experience operating across business functions, Experience operating across geographies, Experience in large IT environments, Experience in complex IT environments, Experience in uncertain IT environments
Nice to Have
Broad IT management experience, Project management experience, Service management experience, Familiarity with technical concepts in infrastructure, Familiarity with technical concepts in applications
What You'll Do.
Assure projects meet regulatory requirements
Assure systems meet regulatory requirements
Assure solutions meet regulatory requirements
Assure services meet regulatory requirements
Assure 3rd party supplier deliveries meet requirements
Ensure automated technologies operate within frameworks
Ensure autonomous technologies operate within frameworks
Support training development
Support education development
Support awareness campaign development
Contribute to continuous improvement of IT Policies
Contribute to continuous improvement of IT standards
Contribute to continuous improvement of IT procedures
Complete Regulatory Impact Determination
Update Regulatory Impact Determination
Review System lifecycle deliverables
Participate in review of Exceptions
Participate in review of CAPA
Participate in review of Deviations
Participate in review of Changes
Participate in review of Incidents
Participate in review of Problems
Define validation planning
Define reporting processes
Lead Supplier Assessment
Participate in Supplier Assessment
Act as QM point of contact
Drive accountability for Quality data completeness
Drive accountability for Quality data accuracy
Drive accountability for Quality data currency
Quality review processes
Increase levels of quality
Increase levels of compliance
Engage in life-long-learning
Engage in continuous professional development
Support development of skills
Support development of capabilities
How You'll Work.
Team & Collaboration
Representatives across IT functions; Representatives across BTGs; Global IT Quality Management professionals
Process & Methodology
Quality Plan, Validation planning, Reporting processes
Full Job Description
**Typical Accountabilities:** * Accountable for the application of Quality Management processes and services to assure that projects, systems, solutions and services delivered by IT and their 3rd party suppliers meet AZ internal and external regulatory requirements * Accountable for IT quality and compliance governance across AI-enabled manufacturing systems, ensuring automated and autonomous technologies operate within approved regulatory, quality, and enterprise governance frameworks. * Act upon risks and issues in order to raise compliance and quality levels within IT and the business * Supports the development and roll out of training, education and awareness campaigns for quality and compliance. * Contributes to the continuous improvement of IT Polices, standards and procedures. * Collaborates with system/business process owner to complete or update the Regulatory Impact Determination (RID) as per the procedure to ensure an understanding of the Regulatory applicability (GxP, SOx, Data Privacy etc.), business, technical, software category, and regulatory risks. * Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on GxP impact, validation lifecycle requirements, and quality, and compliance requirements. * Participate in the review and approval of Exceptions, CAPA, Deviations, Changes, Incidents and Problems ensuring timely completion and update of System Lifecycle deliverables. * Collaborates with the IT Project Manager to define the Quality Plan, processes, validation planning, and reporting processes. * Leads / Participates in the Supplier Assessment to ensure that IT Suppliers meet AZ Regulatory requirements. * Act as a QM point of contact for any potential internal and/or regulatory inspection * Driving accountability for the completeness, accuracy and currency of Quality related data through effective monitoring, tracking and reporting * Process authoring, ownership, lead, qualit
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