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 PositionThis role is based in the Global Device Quality organization which has the end-to- end responsibility of leading and managing the quality aspects of developing medical devices, drug-device combination products and packaging to deliver the pharmaceutical pipeline. We provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures as well as technical and compliance guidance considering the relevant standards and regulatory requirements for medical devices, combination products and packaging. We work closely with Device Development, local si and Medical Device Technical Teams during development, industrialization and product lifecycle to ensure product integrity of design and manufacturing process specifications. We leverage our external partners in order to offer flexibility and know-how to our internal capacity, at the right cost and quality. We enable our partners to reliably deliver compliant, quality products to our supply chain customers, so that we can meet the needs of patients worldwide. We accomplish our mission through cross-functional collaboration focused on continuous improvement, embedding quality and reliability into the design, and ensuring quality process excellence.
The Opportunity:As an integral part of Global Device Quality Management, the Device Supplier Quality Manager collaborates with device and packaging development, device industrialization as well as device project teams in a matrix organization. Furthermore:
Quality assurance oversight of external GxP suppliers including CMOs to ensure compliance with regulations, standards and Roche requirements for the development, manufacturing, and post market quality oversight for medical devices and combination products
Oversight of all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: method validation, Roche and Health Authority audits, complaint handling, and regulatory submissions, act as SME in Supplier Qualification and Maintenance audits
Quality Assurance role in Change Controls and Deviations involving suppliers of medical devices and drug-device combination products components and facilitation of systematic root chase assessments (RCA)
Coordination of the Quality support for medical devices and drug-device combination products between Global Device Quality and the local QA/QC teams at Roche plants such as Kaiseraugst, Hillsboro, South San Francisco, Mannheim, etc., that will be responsible for the clinical and commercial release of medical devices and drug-device combination products
Additionally, you will:
Establish work priorities to meet project targets and timelines
Maintain up-to-date status on all required job related training and strive to continuously improving knowledge and skills in quality, compliance, and technology
Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
You hold a degree in an Engineering or Science discipline with a thorough understanding of the biotechnology industry and specifically of combination products and medical devices. Furthermore:
Working knowledge of ISO 13485, 21 CFR 820, EU MDR and ISO 14971, sound understanding of Quality Compliance, Quality Engineering, and Audits & amp; Inspections Management
Ability to educate teams and organization on Design Controls as it applies to medical devices and combination products, and related topics
Demonstrated capability of applying risk management concepts and tools
Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
Fluency in English (Fluency in a second language is a plus)
Demonstrated problem solving and decision-making skills including hands-on working experience with quality-related tools, Six Sigma / DMAIC
Experience in working in agile environment and usage of lean tools
This position requires up to 30% travel. Sounds interesting? Then apply now!
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. 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.
