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, quality review and/or approval as appropriate

The role works closely with representatives across IT functions and BTGs, acting upon risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.

As part of a high performing team of Global IT Quality Management professionals, the role will actively engage in life-long-learning and continuous professional development.  This will include supporting the development of skills and capabilities to keep up with the pace of change of technology and the evolving regulatory landscape.

Education, Qualifications, Skills and Experience

Essential:

• BA, BSc in Computer or Life Sciences or equivalent, with 3-5 years of experience in the pharmaceutical industry regulatory requirements

• Experience of providing regulatory support including validation of laboratory and business applications.

• Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley

• Experience of contributing to implementation of a Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made

• Experience of operating across business functions and geographies in large, complex and sometimes uncertain IT environments

Desirable

• Broad IT management experience including project or service management

• Familiarity with technical concepts in infrastructure or applications

• External qualifications such as ISPE PCC CPIP and ISACA CISM

Date Posted

Closing Date

AstraZeneca 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.