Director Quality Standards & Documents
AstraZeneca AB / Kemistjobb / Göteborg
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hela Sverige Do you have expertise in, and passion for Quality Management System, Document Management and Authoring? Would you like to apply your expertise influencing and actively shaping the "quality mindset" throughout our R&D organisation? Then this position might be the right one for 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.
We are now recruiting for a Director Quality Standards & Documents (QSD) position to join our QSD team within R&D Quality Assurance. R&D QA is an independent global assurance function in AstraZeneca R&D maintaining the R&D Quality Management System (QMS) and assessing quality based on audits, inspections and self-reported quality issues. We promote and strive towards a state where everyone acknowledges that quality is a key contributor to sustainable business success, and that quality arises from every individual's contribution to a 'right-from-me' mentality.
What you'll do
As a Director QSD you will be part of our ambition to raise the quality mindset across the business, deliver knowledge and results via our quality processes across R&D. You will be the QMS Lead, responsible for driving the strategic development of our QMS and Procedural Document model, spanning across AZ R&D.
In addition you will:
* Collaboratively author and lead the maintenance of Global Standard:Quality for R&D
* Be the Owner of the R&D Procedural Document Model (document hierarchy, types, definitions etc.) and related Global Standards.
* Be our Technical Writing expert, providing good authoring advice and critical review of R&D owned documents to develop authors' writing skills and ensure standards are achieved.
* Lead projects to drive radical simplification and standardisation in collaboration with stakeholders
* Develop and provide state of art training materials, communication, coaching and mentoring
* Provide general support related to regulatory authority inspections as required
* May occasionally conduct audits, due diligence and inspections activities.
* Maintain knowledge of relevant industry information affecting quality and compliance arena
With this in mind the role is best suited to candidates that thrives in a dynamic environment having a proactive mindset and strategic thinking. It is also important to have a 'solutions focused' attitude and the ability to generate simple solutions to complex challenges. You communicate effectively with QA colleagues and business stakeholders, promoting a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits.
Essential for the role
* Degree level education, or significant experience in pharmaceuticals or a related industry
* Deep knowledge in Quality System Management and Process Management
* Excellent analytical, written and oral communications skills
* Fluent in written and spoken English
* Strong collaborative, influencing and interpersonal skills with high curiosity to understand business environment
* Skilled at managing & using technology
* Ability to maintain and create professional networks with partners
Desirable for the role
* Experience in managing regulatory health authority GxP Inspections
* Audit expertise
* Project Management and Change Enablement experience
Why AstraZeneca?
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It's our purpose that drives us, every day. Interested? Come and join our journey.
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 17 May, 2023. Welcome with your application!
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2023-05-17
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-164862".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Kontakt AstraZeneca
nadja.bergman@astrazeneca.com Jobbnummer 7703993
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