At Roche, you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted, and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The role The Roche Diagnostics International Quality & Regulatory function governs the quality of our medical devices. Our quality assurance team ensures the highest standards for qualification & validation activities performed by our business partners. They develop cutting-edge in-vitro medical devices, assays, laboratory information solutions, and cloud-based offerings in the medical domain, including R&D, manufacturing, and end-user services.
Our new global modular quality management system simplifies our process landscape and empowers our validation and qualification teams to shape our future while maintaining high-quality standards.
Your responsibilities as a Quality Assurance Manager include: Act as an independent Quality Partner for our qualification & validation business teams.
Perform comprehensive review and approval of validation and qualification artifacts involved in the system lifecycle.
Enable our business partners to develop and execute compliant and efficient qualification & validation strategies based on our global quality management system.
Who You Are Technical or scientific degree or completed training in a technical profession, with at least 1 year of hands-on experience in qualification and/or validation in GxP-regulated environments.
Experienced in quality management, particularly in equipment qualification or process validation, ideally within medical devices or in vitro diagnostics (ISO 13485, FDA QSR).
An independent, agile, and open-minded team player capable of asserting yourself.
Fluent in German (for daily communication and documentation) and English (C1 level or higher; interviews conducted in German).
Apply now and become part of our team to shape the future together!
Who we are Driven by the goal of a healthier future, over 100,000 employees worldwide are dedicated to advancing science and ensuring access to healthcare for all. Our efforts have resulted in over 26 million treatments with our medicines and more than 30 billion tests with our Diagnostics products. We foster creativity, explore new possibilities, and aim high to deliver life-changing healthcare solutions with a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
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