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AstraZeneca Science IT is building an outstanding organization at the forefront of the digital revolution in healthcare. We're applying technologies such as AI, machine learning, software and data engineering and analytics to provide critical insights. Our goal is to engage with our stakeholders as a strategic partner in delivering life-changing medicines to our patients. Now we have an open position for an Associate Quality Manager to join our growing Quality Management team. We are truly global in scale with resources in Asia, EU, North America and South America.
Main Duties and Responsibilities
The team is professionals that understand AZs business processes and experts at integrating business appropriate risk management techniques. We consult and educate the business and the broader workforce on effectively integrating Compliance Requirements into all IT Lifecycle activities.
You will be protecting AZ License to Operate through delivery and maintenance of compliant innovation, projects and services. The role includes responsibility to facilitate the realization of the Quality Management strategy for specific areas in Quality Management. This is a meaningful role that will act upon risks and issues in order to raise compliance and quality levels within IT and the business. Collaborate with system/business process owners and IT Project Manager to define the quality plan, processes, validation planning and reporting processes.
* Review of System lifecycle deliverables including RID, specifications, protocols, reports, and the Test Closure Memo with a focus on cGMP impact, validation lifecycle requirements, and quality, and compliance requirements
* Participates in the Supplier Assessment to ensure that IT Suppliers meet AZ Regulatory requirements
* Act as a QC point of contact for any potential internal and/or regulatory inspection
Are you a forward-thinking person who share our passion for science? To succeed in this role, you need strong interpersonal skills and be capable of discussing technical IT terms with a non-technical business audience. Experience of operating cross-functional and across geographies in large, complex and sometimes uncertain IT environments. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
* Ability to make pragmatic decisions by analysing highly complex situations and assessing risks. Stabilizing strategic and tactical compliance/quality 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
* Familiarity with technical concepts in infrastructure or applications
About AstraZeneca Gothenburg Hub
Our stunning campus in Gothenburg is one of AstraZeneca's three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we've built a series of environments where innovation can happen.