Stellenbezeichnung: Quality Manager, AI / Machine Learning, Oncology R&D (fixed term)
Arbeitsort / Location: München, Bayern
Job Beschreibung: Fixed term contract, approximately 10 months based on-site in Munich
Do you have expertise in, and passion for quality and compliance, and are experienced in Quality Management and Assurance (with background in AI/ML) in the pharmaceutical industry? Would you like to apply your expertise to impact the drug development in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
Our Computational Pathology site in Munich is one of over 400 sites here at AstraZeneca, providing an environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. It’s important to us that you bring your full self to work every day. To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you: After-work events, Lunch & Learns, spacious environment, Sustainable office working environment, events, childcare support and of course the Alps around the corner for hiking, biking and skiing.
At AstraZeneca, Computational Pathology sits within the Oncology Translational Medicine – Cancer Biomarker Development department within our Oncology R&D organisation. The Computational Pathology team was established with the acquisition of Definiens. At our site in Munich, we are changing the way imaging technologies are combined with other Omics technologies and clinical patient data to offer outstanding insight and impact. We empower translational science to transform cancer treatment with impactful information derived from biomedical image by innovating at the interface between Artificial Intelligence, pathology and data sciences.
What you’ll do
The successful candidate will work with process owners and subject matter experts to support the development of Quality Management framework for artificial intelligence algorithm development. Additionally, the Quality Manager will be responsible for the development of procedural documents and quality compliance documentation in accordance with Quality Management Systems, Good Clinical Practice (GCP), and Good Machine Learning Practice (GMLP) in collaboration with internal quality experts.
Provide expertise in quality and compliance
Work with process owners and subject matter experts to support development of Quality Management framework for artificial intelligence algorithm development
Development of procedural documents and quality compliance documentation in accordance with Quality Management Systems, Good Clinical Practice (GCP), and Good Machine Learning Practice (GMLP) in collaboration with internal quality experts.
Essential for the role
Degree or equivalent professional qualification in related field
Experience in a Quality Assurance or Quality Management related to biomarker development field
Knowledge of international guidelines ICH-GCP, GMLP, IVDR
Prior experience in a quality management supporting clinical development of biomarkers; knowledge of regulatory requirements for biologics products, software development, analysis and qualification/ validation
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial – finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Competitive salary & benefits
Close date: 15/07/2023
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn:
Inclusion & Diversity:
Date Posted 18-Jul-2023
Closing Date 14-Aug-2023
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 authorization and employment eligibility verification requirements.
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