Associate Director, Quality Management - SaMD, Oncology R&D (m/f/d)
Join AstraZeneca as an Associate Director, Quality Management - SaMD, Oncology R&D (m/f/d) at our Munich, Germany office.
Are you passionate about quality and regulatory topics in healthcare? Interested in integrating artificial intelligence quality practices into software research and development? You will work within a multidisciplinary team to support precision medicine solutions for Oncology.
About AstraZeneca
AstraZeneca is a global biopharmaceutical company dedicated to discovering, developing, and commercializing medicines for serious diseases. We foster a collaborative environment across over 400 sites, including Computational Pathology Munich, offering various employee benefits and a supportive workplace culture.
What You’ll Do
* Support the implementation of a QM system compliant with EN ISO 13485:2016 for medical device software.
* Develop and update SOPs, forms, and templates to ensure compliance with internal and external standards.
* Conduct training on SOPs and relevant standards.
* Ensure quality assurance of software development processes in line with IEC 62304, international AI standards, and internal procedures.
* Contribute to product technical documentation.
* Assist in preparing internal and external quality audits.
Essential Qualifications
* Degree in engineering, natural sciences, computer science, or related field, or 5 years of equivalent experience.
* Minimum 10 years of relevant industry experience with at least 2 years in SaMD design and development.
* Knowledge of norms like ISO 13485, IEC 62304, ISO 14971.
* Excellent communication skills in English and attention to detail.
* Ability to manage complex projects across multiple disciplines.
Desirable Skills
* Experience with In-vitro Diagnostics (IVD) medical devices and understanding of performance evaluation.
* Knowledge of drug development and companion diagnostics.
Benefits
* Opportunities for personal development and lifelong learning.
* Diverse, inclusive work environment with trust and co-creation space.
Additional Details
Seniority level: Associate
Employment type: Full-time
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
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