Quality Assurance Manager Q&V; Quality Partner Infrastructure

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.

• 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.

• 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 ISO
  13485 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.

• 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.

• 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.

Rotkreuz (primary location).

Roche is an Equal Opportunity Employer.