Associate Director, Quality Management - SaMD, Oncology R&D (m/f/d)
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Job Overview
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 right place for you! In this position, you will work 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 dedicated to the discovery, development, and commercialization of prescription medicines for serious diseases. We are committed to innovation and improving patient outcomes worldwide.
Site Description - Munich, Germany
Welcome to Computational Pathology Munich, one of over 400 AstraZeneca sites. We foster a collaborative environment where everyone can be themselves. Our site offers after-work events, lunch & learns, a spacious and sustainable office environment, family and childcare support, and proximity to the Alps for outdoor activities.
Business Area
We focus on transforming lives through early diagnosis and treatment, with the industry’s highest number of early-stage cancer trials, bringing us closer to finding cures every day.
Responsibilities
* Support the implementation of a QM system compliant with EN ISO 13485:2016 for medical device software.
* Define and improve processes by creating/updating SOPs, forms, and templates to ensure compliance with internal and external standards.
* Deliver training on SOPs and applicable standards.
* Ensure quality assurance of software development processes in compliance with IEC 62304, international AI standards, and internal policies.
* Contribute to product technical documentation.
* Assist in preparing internal and external quality audits.
Qualifications
* Degree in engineering, natural sciences, computer science, or related field, or 5+ years of relevant experience.
* Minimum of 10 years of relevant experience in pharma or medical devices, with at least 2 years in SaMD design and development.
* Good knowledge of relevant standards (ISO 13485, IEC 62304, ISO 14971).
* Excellent English communication skills and attention to detail.
* Ability to manage complex projects and influence multidisciplinary teams.
Desirable Skills
* Experience with In-vitro Diagnostics (IVD) medical devices and understanding of performance evaluation.
* Knowledge of drug development processes and companion diagnostics.
Benefits
* Opportunities for professional growth and lifelong learning.
* Diverse, inclusive, and unbiased work environment.
* Supportive culture emphasizing trust, appreciation, and co-creation.
AstraZeneca promotes diversity and equality of opportunity. We are committed to building an inclusive team and welcome applications from all qualified candidates regardless of background. We comply with all applicable laws and regulations regarding non-discrimination and employment eligibility.
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industry: Pharmaceutical Manufacturing
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