OBS! Ansökningsperioden för denna annonsen har
Experienced in IT Regulatory Support with a progressive approach? Would you like to be part of a globally located team with various backgrounds and experiences? Then this might be your next opportunity!
In this role your mission will be to contribute to protecting AstraZeneca's license to operate through industry leading delivery and maintenance of excellent compliant innovation, projects and services. This function will also coach and educate the business and broader workforce on optimally integrating Compliance Requirements into all IT Lifecycle activities. You will work on a truly global scale, with collaborators across Asia, EU, North America and South America - together supporting a broad stakeholder community. The role works closely with representatives across business and IT functions, acting upon risks and issues to pro-actively strive to increase the levels of quality and compliance across IT.
You will use your pharmaceutical regulatory compliance experience and intelligence to support and deliver an integrated IT QM strategy. The role is responsible for understanding and applying regulatory compliance policies and standards. Using a risk-based approach, proactively engage with and drive IT inspection readiness activities for sites within your scope as well as contribute to the creation of a global plan. In addition, the role will support the delivery of compliant projects and programmes.
With your initiative and dedication to identify and deliver continuous improvement opportunities, you will be expected to:
* Utilise the quality management planning approach and processes ensuring that organisational, inspection and supplier compliance risks are identified, assessed, and mitigated in support of the license to operate
* Influence compliance activities over project delivery methodologies (e.g. Agile, Waterfall), processes and underpinning tools to build value and simplification
* Actively contribute towards the overall planning, governance and Tier reporting of key metrics and measures
* Utilise Quality insights to improve performance, productivity and alignment to our processes, and to drive value for peers and stakeholders
* Support the development and delivery of integrated strategies for Lean, Tools, Automation, Digital and AI
This role needs you who is a progressive IT Quality Management professional that understands the evolving external regulatory landscape and is an expert at integrating business appropriate risk management techniques. Experienced in contributing to implementation of a Quality and/or Compliance strategy with the ability to prioritise and understand the impact of the decisions made You are comfortable with operating across business functions and geographies in large, intricate and evolving IT environments and possess strong change leadership and team working skills. As the role includes collaboration with a non-technical business audience it is also important that you are capable of discussing technical IT-terms in an inclusive manner. You are energetic and high-reaching, and are able to hold self and others accountable for actions.
We also see that you have:
* BA, BSc in Computer or Life Sciences or equivalent, with solid experience in the pharmaceutical industry regulatory requirements
* Knowledge and experience of working with/providing IT regulatory support to Site Quality groups
* Expertise in working with and providing regulatory support, including computerised system validation/assurance activities.
* Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes-Oxley
* Knowledge of emerging regulatory/digital trends and risks affecting the pharmaceutical industry
* Ability to make pragmatic decisions by analysing complex/time-critical situations, assessing risks and identifying mitigating compliance/quality requirements
* Concern for impact, analytically minded and able to prioritise and plan using initiative
* Fluent in Swedish and English
At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
SO, WHAT NEXT?
Are you up for an exciting challenge and ready for making a difference? If so, hit Apply today - but no later than 28th of July 2022.
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