Quality Assurance Manager Q&V (Quality Partner Infrastructure) (80-100%) - #51842

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

The Roche Diagnostics International Global Quality, Regulatory& External affairs function governs the quality of our medical devices. Our team ensures the highest standards for the 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 and include R, manufacturing and end user service organizations.

Our new global modular quality management brings a radical simplification of our process landscape and provides our validation and qualification teams with more freedom and ability to shape our future, while preserving our high quality standards.

The Opportunity

• Act as an independent Quality Partner for our qualification& validation business teams
• Enable our business partners to develop and execute compliant and efficient qualification& validation strategies based on our global quality management system
• Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle
• Based on a deep understanding of our global quality management system: act as ambassador of the global quality assurance processes and thereby enable our business partners to deliver high class medical products
• Shape, live and defend our global quality management system
• Take controlled risks and help in the defense during audits

Who You Are

• Educational Background: Technical or scientific degree or completed education in a technical profession.
• Professional Experience: At least 3 years of practical expertise in the area of qualification and/or validation in GxP environments, with experience or a high level of affinity with quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485 and FDA’s Quality Systems Regulations) regarding Equipment Qualification/Management and data integrity.
• Core Technical Expertise: Experience in at least one of the following areas is a must: Test method validation (including regulatory background) OR Knowledge management and use of AI in the context of quality assurance.
• Language Skills: Although German is the main language of communication and documentation, very good English verbal and written language skills are expected (minimum C1 level; no certification required). Please note that all interviews will be conducted in German.
• Key Mindset& Competencies: Driven by a passion to achieve high quality standards while keeping stakeholders happy, continuous improvement, and challenging the status quo. You are an autonomous, agile, and open-minded team player with the ability to assert yourself, backed by excellent judgment, negotiation, and communication skills.

We provide

• A great and enthusiastic team
• An inspiring working environment
• Substantial fringe benefits

Ready to take the next step? We'd love to hear from you. Apply now to explore this exciting opportunity!

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Rotkreuz. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.