Associate Director Quality Standards and Documents

Do you have expertise in, and passion for Quality and Business Processes? Would you like to apply your expertise influencing and actively shaping the "quality mindset" throughout the R&D organisation? We're looking for people driven by making a difference to patients' and society, dedicated to doing the right thing. Is this you?

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.

Join us as an Associate Director Quality Standards and Documents and be part of an exceptional place to work!

Quality Assurance is a group of 65 Quality Assurance professionals located at R&D sites worldwide. We work in a highly regulated industry. Patients who participate in clinical trials are vulnerable. Hence there are strict regulations by the health authorities, to protect patients, which we need to follow. The health authorities inspect our activities to make sure we are following and interpreting the regulation as intended. As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mind-set for the benefit of our patients.

In our ambition to raise the quality mindset across the business, We now further strengthen how we set standards for quality and provide efficient management of Procedural Documents. In doing this, we are seeking an Associate Director Quality Standards and Documents to in close collaboration with the process owner develop standards and drive the continuous improvement of Procedural Document management to join the Quality Standards and Documents team on one of our key R&D locations.

What you'll do
As an Associate Director Quality Standards and Documents, you plan and drive the development of new or improved solutions in the area of document management with focus on integrated process and system design to ensure effectiveness of processes for business and compliance with adequate regulations. You work in collaboration with the Manage Procedural Documents process owner and other stakeholders, securing life cycle management and business continuity, promoting global consistency, standardization and sharing of best practices. You will also:

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Lead QSD improvement projects and drive simplification to improve ways of working and user experience
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Develop procedural documents
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Train, advice and guide R&D users through the Manage Procedural Document process
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Support audits and inspections
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Be accountable for system compliance according to internal framework and external requirements
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Maintain knowledge and compliance to relevant regulation, policies, standards, SOPs and guidelines

Essential for the role

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Degree level education
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Experience in pharmaceuticals or a related industry
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Excellent analytical, written and oral communications skills
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Proven expertise in system administration and information management
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Experience in pharmaceuticals or a related industry and a good understanding for business processes within area of accountability
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Fluent in written and spoken English
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High ethical standards, trustworthy, operating with absolute discretion
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Strong collaborative, influencing and interpersonal skills
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Skilled at managing & using technology
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Ability to maintain and create professional networks with stakeholders

Desirable for the role

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Project management
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Quality Management

So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.We will go through the applications continuously so please apply as soon as possible but no later than April 28, 2021. Welcome with your application!

Find out more
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Our Gothenburg site: https://www.astrazeneca.com/our-company/our-locations/gothenburg.html

Why AstraZeneca?
Our Gothenburg site is one of AstraZeneca's three strategic science centers. We thrive in a multinational environment working cross-functionally across the globe with AstraZeneca colleagues as well as academic and industry partners. Our way of life is to foster a working environment that nurtures, collaboration, openness and innovation. Therefore, we have created space for meetings, socializing and relaxation, where spontaneous meetings can give birth to new innovations. The unexpected ideas or thoughts that can come from a chat over something as simple as a cup of coffee or a stroll on our "walk and talk" meeting trail.