IT Quality Management Lead

Job Title: IT Quality Management Lead

Career Level - F

Introduction to role

Protecting AstraZeneca's license to operate through the delivery and maintenance of compliant innovation, projects, and services. This function comprises IT Quality Management professionals who understand AstraZeneca's business processes and are experts at integrating business-appropriate risk management techniques. This function will also consult and educate the business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities. The function is truly global in scale with resources in Asia, EU, North America, and South America supporting a broad stakeholder community.

Accountabilities

• Specialise in Quality and Compliance, supporting the overall strategy for IT Quality Management to ensure that systems and services remain compliant in line with changing regulations, sanctions, the broader AstraZeneca IT Strategy, and AstraZeneca Corporate Strategy.

• Utilise your depth of industry experience to set direction for operational performance, metrics, and delivery of IT Quality Management services for International (e.g., Regional/Site inspection readiness and support, local project implementations).

• Establish a forward-looking view of new systems needing sanctions assessment, particularly those related to emerging technologies like AI, and provide support throughout the sanctions assessment process.

• Follow up on IT implications when there are changes to sanctions to ensure all connection points related to IT are fully up to date and maintained, as required by Global Compliance.

• Confirm if IT hardware or software falls under specific legal and technical descriptions and assess whether equipment qualifies for exceptions to regulations.

• Apply export control regulations, sanctions, and related compliance requirements to ensure adherence to international trade laws and regulations in the context of quality management.

• Structure, interpret, and embed local, regional, or top-level IT and specialist compliance policies, standards, and government guidance and regulations through IT and business engagement.

• Drive excellence and simplification in the design of our internal LtO processes ensuring adherence to standards and data principles.

• Collaborate closely with the business and IT teams, ensuring an understanding of the areas of GxP, SOx, Data Privacy applicability, and impact to Sites, Technology (Hardware and Software) based on the business process and use.

• Ensure that IT systems remain compliant throughout their lifecycle with the relevant compliance policies, standards, and government regulations.

• Drive and deliver improvements in our Compliance performance through Lean and automation to continuously improve Quality Management services.

• Embed compliant practices for AI/ML within local projects and programmes.

• Utilise effective education and training to help protect our LtO and embed a compliance culture.

• Act as Process owner for key compliance processes responsible for driving Lean maturity of the processes.

• Act upon risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.

• Identify, communicate, and manage trends in operational compliance risks (including BCP), breaches, and issues, ensuring CAPA to mitigate the risks are discussed and agreed with Stakeholders.

• Drive accountability across IT through effective planning, governance, and reporting of key Compliance metrics and measures by interpreting Quality insights for senior team members.

• Provide compliance input to the preparation for internal management reviews, external regulatory, and internal AstraZeneca inspections as required.

• Drive the continuous monitoring, improvement, and digitisation of our processes, services, and tools through applying LEAN thinking and techniques, and exploiting tools and automation.

• Apply specialist knowledge to support strategic critical thinkingthinking around how to manage compliance activities.

Essential Skills/Experience

• BA, BS in Computer or Life Sciences or equivalent, with 5+ years of experience in the pharmaceutical industry regulatory requirements including export control regulations.

• Knowledge and experience of working with/providing regulatory support including computerised system validation/assurance activities.

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

• Experience of operating at senior levels including leading and managing global teams, operating across business functions and geographies in large, complex, and sometimes uncertain IT environments.

• Experience in establishing a Quality Management Strategy in Life Sciences environment.

• Knowledge of international sanctions and export controls, particularly those impacting IT.

Skills and Capabilities

• Excellent communication, influencing, and relationship-building skills capable of interpreting and discussing technical IT terms with a non-technical business audience.

• Ability to make pragmatic decisions by analysing highly sophisticated/time-critical situations, assessing risks, and stabilising strategic and tactical compliance/quality requirements.

• Concern for impact, analytically minded, able to prioritise and plan using initiative.

• High levels of drive, energy, resilience, and a desire for professional excellence.

• Ability to hold self and others accountable for actions.

• Proven change leadership and team working skills.

• Ability to identify, assess, and mitigate IT-related risks, particularly those arising from sanctions and export controls.

Desirable Skills/Experience

• Broad IT management experience including project or service management.

• Familiarity with technical concepts in infrastructure or applications.

• Understanding of Lean principles, tools, and techniques.

When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

AstraZeneca is a place where technology meets science. Our work has a direct impact on patients by transforming our ability to develop life-changing medicines. We empower the business to perform at its peak by combining powerful science with leading digital technology platforms. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Here you can innovate freely while being supported all the way.

Ready to make an impact? Apply now!

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 authorisation and employment eligibility verification requirements.