Design Quality Partner

hace 2 meses

Sant Cugat del Vallès, España F. Hoffmann-La Roche Gruppe A tiempo completo

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 Position

Who 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 Subchapter 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.

Responsibilities:

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 achievement.
  • Review and approve achievement deliverables within development projects.
  • Represent Pre Market Quality in mQMS Communities and support internal and external audits.
  • Drive 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 CAPA.
  • Model behavior to support and enable new ways of working and a culture of continuous improvement.

Other Responsibilities to advance the work of the organization:

  • Embed and continuously improve knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.
  • Ensure effective change management in Product Development Quality, R&D and other functions.
  • Foster a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout Product Development Quality and other functions.
  • Serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.
  • Drive decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementation.
  • Serve as a coach, supporting colleagues to grow and develop their skills, fostering a learning and development-oriented environment.

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 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.

Location: 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

Who we are

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.

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