Position Overview
Act as an independent Quality Partner for our qualification & validation business teams, enabling partners to develop and execute compliant and efficient qualification and validation strategies based on our global quality management system. Responsibilities
Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle. 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. Enable our business partners to develop and execute compliant and efficient qualification and validation strategies based on our global quality management system. Qualifications
Technical or scientific degree or completed education in a technical profession. At least 3 years of practical expertise in 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 ISO13485 and FDA’s Quality Systems Regulations) regarding equipment qualification/management and data integrity. Core technical expertise 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
German is the main language of communication and documentation; very good English verbal and written skills are expected (minimum C1 level; no certification required). 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. Autonomous, agile, and open‑minded team player with the ability to assert yourself, backed by excellent judgment, negotiation, and communication skills. Location
Rotkreuz (primary location). Equal Opportunity Statement
Roche is an Equal Opportunity Employer.
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Act as an independent Quality Partner for our qualification & validation business teams, enabling partners to develop and execute compliant and efficient qualification and validation strategies based on our global quality management system. Responsibilities
Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle. 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. Enable our business partners to develop and execute compliant and efficient qualification and validation strategies based on our global quality management system. Qualifications
Technical or scientific degree or completed education in a technical profession. At least 3 years of practical expertise in 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 ISO13485 and FDA’s Quality Systems Regulations) regarding equipment qualification/management and data integrity. Core technical expertise 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
German is the main language of communication and documentation; very good English verbal and written skills are expected (minimum C1 level; no certification required). 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. Autonomous, agile, and open‑minded team player with the ability to assert yourself, backed by excellent judgment, negotiation, and communication skills. Location
Rotkreuz (primary location). Equal Opportunity Statement
Roche is an Equal Opportunity Employer.
#J-18808-Ljbffr
Quality Assurance Manager Q&V (Quality Partner Infrastructure) (80-100%) Arbeitgeber: F. Hoffmann-La Roche AG
F. Hoffmann-La Roche AG bietet eine herausragende Arbeitsumgebung in Basel, die von Innovation und Zusammenarbeit geprägt ist. Als Arbeitgeber im biopharmazeutischen Sektor fördern wir das Wachstum unserer Mitarbeiter durch kontinuierliche Weiterbildung und Entwicklungsmöglichkeiten. Unsere Unternehmenskultur legt Wert auf Vielfalt und Teamarbeit, was es zu einem idealen Ort macht, um bedeutende Beiträge zur Zukunft der Gesundheitsversorgung zu leisten.
