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Roche

Global pharmaceuticals and diagnostics company

Design Quality Partner

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSant Cugat del Vallès, Barcelona, SpainNo salary listed

About the Job

Requirements

  • A bachelor's degree in Engineering, Science, Business Administration, or a related field.
  • At least 3 years of experience in Quality Management Systems and design controls.
  • Strong understanding of quality and regulatory requirements for reviewing Design History File content, such as ISO 13485, FDA, GMP, or requirements from other heavily regulated industries.
  • A solid understanding of or curiosity about artificial intelligence capabilities and models.
  • Technical writing, data interpretation, communication, collaboration, and facilitation skills.
  • Ability to focus on the appropriate degree of detail.
  • Willingness to travel internationally depending on business activities.

Responsibilities

  • Partner with Strategic Quality Partners and cross-functional stakeholders to ensure milestone deliverables are complete and appropriate.
  • Review and approve milestone deliverables within development projects, enabling risk-informed decision-making.
  • Ensure timely execution and quality process management for design change requests, non-conformances, and corrective and preventive actions.
  • Reduce complexity and standardize deliverables, templates, review processes, and content across projects using pragmatic, agile solutions.
  • Support internal and external regulatory audits.
  • Embed and continuously improve knowledge sharing and retention within Pre-Market Quality.
  • Lead and support change management across Product Development Quality, Research and Development, and related functions.
  • Build and inspire global project teams through matrix leadership, ensuring customer solutions contribute to the Roche Diagnostics vision.
  • Coach colleagues to support their growth and foster a learning-oriented environment, particularly for junior team members.

Desired Qualifications

  • AI capabilities and models are highly valued for supporting technology-driven compliance initiatives.

About the Company

Roche

Global pharmaceuticals and diagnostics company

Roche is a global leader in pharmaceuticals and diagnostics. It develops medicines and diagnostic tools that help detect, monitor, and treat diseases, using research and biotechnology to drive new therapies and tests. Roche combines drug development with in-house diagnostic products to support personalized medicine, where treatments are tailored to individual patients based on test results. Its approach differs from many peers by integrating drug discovery with diagnostic capabilities and by expanding its research through strategic acquisitions (like Genentech) to strengthen its biotechnology and R&D capabilities. The company’s goal is to improve patient outcomes and healthcare worldwide by delivering reliable medicines, accurate diagnostic tests, and data-driven care.

Company size
1-10
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1896

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