Quality Assurance Manager Q&V (Quality Partner Infrastructure) (80-100%)
RocheJobsCloseBy Editorial Insights
Roche is hiring a Quality Assurance Manager Q&V to serve as an independent Quality Partner for qualification and validation across a global modular quality management system. You will enable business partners to craft compliant, efficient Q&V strategies, review and approve artifacts throughout the system life cycle, and defend QA processes during audits while pushing for continuous improvement. The ideal candidate has 3+ years in GxP qualification/validation, experience with ISO 13485 and FDA QSR, and either test method validation or knowledge management and AI in QA; strong German with excellent English. Apply with concrete examples of independent oversight, data integrity, stakeholder influence, and cross-functional impact; highlight willingness to work onsite Rotkreuz and commitment to Roche’s inclusive culture.
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
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&D, 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.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.