Associate Director, Quality Management - SaMD, Oncology R&D (m/f/d)
Associate Director, Quality Management - SaMD, Oncology R&D (m/f/d)
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Job Description
Are you enthusiastic about quality and regulatory topics in the healthcare industry Would you like to learn and apply artificial intelligence quality practices into software research and development Then AstraZeneca might be the one for you! In this position you will be working within a multi-disciplinary team to support the delivery of precision medicine solutions for our Oncology portfolio. This role is based at our Munich Germany office.
ABOUT ASTRAZENECA
AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies.
SITE DESCRIPTION - Munich Germany.
Welcome to Computational Pathology Munich one of over 400 sites here at AstraZeneca providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZenecas priorities its important to us that you bring your full self to work every day. To help you maintain your best self heres 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 family and childcare support and of course the Alps around the corner for hiking biking and skiing.
BUSINESS AREA
From diagnosis to later stage development were laser-focused on leading the way forward to create solutions that transform lives. We are focused on identifying and treating patients earlier where there is greater curative potential. With the greatest number of early-stage cancer trials in the industry we are getting closer to finding cures every day.
What youll do
Support the implementation of a QM system that complies with EN ISO 13485:2016 for medical device software.
Define and improve processes by creating/updating SOPs forms and templates to ensure conformity with applicable internal and external requirements.
Deliver trainings on SOPs and applicable standards.
Quality Assurance of software development process to ensure compliance with IEC 62304 international AI standards and internal processes.
Write and contribute to product technical documentation.
Support preparation of internal and external quality audits.
Essential for the role
Degree in engineering natural sciences computer science or related discipline or 5 years of equivalent working experience.
At least 10 years of relevant work experience in pharma or medical device industry with focus on quality and regulatory topics and 2 years in SaMD design and development.
Good knowledge of relevant norms and regulations for SaMD (ISO 13485 IEC 62304 ISO 14971).
Excellent written and verbal communication skills in English and an eye for detail.
Ability to drive influence manage execute and deliver results for complex multi-functional interdisciplinary projects.
Desirable for the role
Experience with In-vitro Diagnostics medical devices (IVD) and understanding of IVD performance evaluation.
Understanding of drug development process and companion diagnostics.
Benefits
Individual development opportunities and a focus on lifelong learning.
A diverse inclusive and unbiased work environment.
Trust appreciation and space for co-creation.
Wellbeing and Mobility Benefits
Date Posted
13-Juni-2025Closing Date
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.
Required Experience:
Director
Employment Type
Full-Time
