AstraZeneca

ITQualityManager

$450–750k ~AI est. China FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Problems you'll solve

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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