Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionWho we are
A healthier future. It’s what drives us to innovate.
To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
The Opportunity:
We are seeking a highly motivated Design Quality Partner (DQP) to join our Product Development Quality organization, reporting to the Subchpater lead Product Development Quality. As the Design Quality Partner, you will be responsible for ensuring effective partnerships within Q&R and related functions, enabling project acceleration by efficient and timely landmark achievement. You enable an efficient document review process by focusing on the output of the design control deliverables and balancing project workload across the customer areas through flexible workload allocation. You are an example of living collective success by working, believing and empowering each other.
Responsabilities:
Key Responsibilities to drive business results and customer value:
Partner with SQP and applicable collaborators to ensure completeness and appropriateness of applicable achievement deliverables to ensure landmark readiness and achievementReview and approve achievement deliverables within development projectsRepresent Pre Market Quality in mQMS Communities and support internal and external auditsDrive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other)Ensure timely execution and quality process management for design change requests, NCs and CAPAModels behavior to support and enable new ways of working and a culture of continuous improvement
Other Responsibilities to advance the work of the organization:
Who you are:
Bachelor's degree in engineering, business administration or a related field and 3+ years experience or MBA or advanced degree is considered an advantage.Strong design control/mQMS understandingKnowledge and understanding of Quality and Regulatory requirements for review of design history filecontentKnowledge of Regulations pertaining to the environment (i.e. ISO 13485, FDA, GMP, others)Technical writing and data interpretation skills, including ability to focus on the right degree of detail when reviewing deliverablesLocation: Sant Cugat del Vallès
Leadership Skills:
You are also responsible for building, and providing effective matrix-leadership for a global project team. Doing so in a manner that is consistent with the Roche Values and leadership capabilities. You will seek to inspire and lead your global team to create transformative solutions, and to influence their prioritization and uptake in the wider organization, in order to ensure that customer solutions are at the forefront of Pre Market Quality and deliver its optimal contribution to the Roche Diagnostics Vision.
The Design Quality Partner is expected to demonstrate the Roche Operating Principles and contribute to the Roche Group. The Roche Operating Principles are:
● Put patients first
● Follow the science
● Act as one team
● Embrace differences
● Accelerate learning
● Simplify radically
● Make impact now
● Think long term
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.