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&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
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
#J-18808-Ljbffr
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
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
#J-18808-Ljbffr
Quality Assurance Manager Q&V (Quality Partner Infrastructure) (80-100%) Arbeitgeber: Roche Holding AG
Roche Holding AG ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Basel eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung sowie einer Kultur der Zusammenarbeit und Innovation, ermöglicht Roche seinen Mitarbeitern, bedeutende Beiträge zur Qualitätssicherung in der Herstellung zu leisten. Die Möglichkeit, an Transformationsprozessen mitzuwirken und Einfluss auf strategische Entscheidungen zu nehmen, macht diese Position besonders attraktiv für engagierte Fachkräfte.
