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.

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.

Who we are

Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us create value through process excellence and continual improvement efforts. Quality is every patient’s right and every employee’s responsibility. Our Chapter in Pre-Market Quality is accountable for providing quality support to Development Projects to ensure quality, and filing readiness according to internal and external requirements.

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.

The Opportunity

As DQP, you will be responsible for ensuring effective partnerships within Q&R and related functions, enabling project acceleration by efficient and timely milestone 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, trusting and empowering each other.

You will partner with SQP and applicable stakeholders to ensure completeness and appropriateness of applicablemilestone deliverables to ensure milestone readiness and achievement.

You will review and approve milestone deliverables within development projects.

You will represent Pre Market Quality in mQMS Communities of Practice (e.g. for IRM/ Change Control/ D&D module).

You will support internal and external audits.

You will drive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other).

You will ensure timely execution and quality process management for design change requests, NCs and CAPA.

You will model behavior to support and enable new ways of working and a culture of continuous improvement.

You will adopt Risk Enabler in decision making.

You will reduce complexity and drive continuous improvement across customer areas with pragmatic solutions.

The Design Quality Partner (d/f/m) is expected to demonstrate the Roche Operating Principles, to deliver optimal contribution to the Roche Diagnostics Vision and to advance the work of the organization. The Design Quality Partner (d/f/m) will seek to inspire and lead a 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 by:

Embedding and continuously improving knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.

Ensuring effective change management in Product Development Quality, R&D and other functions.

Fostering a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout Product Development Quality and other functions.

Serving as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.

Driving decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementation.

Serving as a coach, supporting colleagues to grow and develop their skills, fostering a learning and development-oriented environment.

Reducingcomplexity and drive continuous improvement across customer areas with pragmatic solutions.

Inspiring the organization to think in terms of impact and outcomes rather than tasks.

Who You Are

You bring with a 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 understanding

Knowledge and understanding of Quality and Regulatory requirements for review of design history file content

Knowledge 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 deliverables

Effective matrix-leadership for a global project team

Strong communication, collaboration and facilitation skills

As this position is part of a global organization, international business travel will be required depending upon the business location of the successful candidate and ongoing business project activities.

Your application

We make it easy! All you need to do is upload your CV in English. Further documents will be requested if required.

We look forward to receiving your application!

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 Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.