Quality Assurance Manager

Location: Rotkreuz

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 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 Opportunity

The Roche Diagnostics International Global Quality, Regulatory & External Affairs function governs the quality of our medical devices, ensuring world-class standards across the qualification and validation activities performed by our cross-functional business partners. Our partners develop cutting-edge in-vitro medical devices, diagnostic assays, laboratory information solutions, and cloud-based healthcare offerings spanning R&D, manufacturing, and end-user service organizations.

Through our new global modular quality management system, we radically simplify the process landscape—giving validation and qualification teams greater autonomy to shape the future while maintaining uncompromising standards.

Serve as an Independent Quality Partner: Act as a strategic, objective Quality Partner embedded alongside qualification and validation teams across R&D, operations, and service units.

Drive Compliant & Agile Validation Strategies: Guide business partners in formulating, tailoring, and executing robust qualification and validation strategies aligned with our global modular quality management framework.

Review & Approve System Life Cycle Deliverables: Provide thorough, objective reviews, actionable feedback, and formal quality approval for qualification and validation artifacts across all stages of the system life cycle.

Deliver Cutting-Edge Medical Solutions: Enable cross-functional teams to bring advanced in-vitro diagnostics, assays, laboratory information systems, and cloud platforms safely to market.

Champion Quality Processes: Act as an ambassador for global quality assurance principles, fostering strong cross-departmental alignment and operational discipline.

Shape & Optimize the QMS Framework: Continuously refine, live, and strengthen our simplified global modular quality management system to support organizational agility and scalability.

Enable Informed Risk-Taking: Champion prudent, data-driven, and controlled risk management strategies to streamline validation efforts without compromising product safety or compliance.

Lead Audit Readiness & Defense: Actively represent, articulate, and defend qualification and validation practices, records, and rationales during internal, regulatory, and external partner audits.

Who You Are

Educational Background: You hold a degree in a technical or scientific discipline (e.g., Engineering, Biotechnology, Computer Science, Natural Sciences) or have completed equivalent vocational technical training.

GxP Qualification & Validation Experience: You bring a minimum of 3 years of hands-on, practical expertise in qualification and/or validation within regulated GxP environments.

Specialized Domain Competence: You possess demonstrated experience in at least one of the following key domains:Test method validation (including relevant international regulatory frameworks).Knowledge management and the application/governance of AI tools in quality assurance contexts.

Medical Device & IVD Regulatory Acumen: You bring direct experience with, or a strong affinity for, medical device and in-vitro diagnostics quality management systems (specifically ISO 13485 and FDA Quality System Regulations / 21 CFR Part 820), with strong familiarity in equipment qualification, equipment management, and data integrity standards.

Bilingual Fluency (German & English): You possess professional-level German and English communication skills (written and spoken, minimum C1 equivalent without requiring formal certification). As German is the primary language for internal collaboration and documentation, all candidate interviews will be conducted in German.

Quality Mindset & Stakeholder Balance: You are driven by a commitment to uncompromising quality while effectively balancing stakeholder needs, continuously challenging the status quo, and identifying opportunities for process enhancement.

Collaborative & Assertive Leadership: You are an autonomous, agile, and open-minded team player with strong interpersonal skills, sound judgment, proven negotiation capabilities, and the confidence to advocate for compliant decisions.

Please note that an internal candidate has been identified for this position. However, we are committed to considering all qualified applicants. If your background and experience align with the role requirements, we welcome and encourage your application

Ready to bring your unique qualities to Roche and make an impact? Apply now and join us in our mission to shape the future of healthcare.

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.