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Ops Quality Senior Quality Partner

Lead qualification and validation activities to ensure regulatory compliance and product quality
Mannheim, Baden-Württemberg, Germany
Senior
yesterday
Roche

Roche

A global healthcare company that specializes in pharmaceuticals and diagnostics to improve patient outcomes and advance medical science.

Operations Quality - Senior Quality Partner

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 Position

As Operations Quality - Senior Quality Partner, you are significantly involved in improving the quality of life for patients worldwide. Your contribution ensures that our diagnostic products and services are safe and of high quality and meet customer requirements throughout the entire lifecycle. You act in accordance with our Roche Operating Principles, drive innovations, and enable compliant processes that lead to faster and more efficient development. You take responsibility and use your expertise to shape our quality management in a future-oriented manner.

Your new team

You will be part of the Diagnostics Division in the DQOGA – the Quality Assurance Job Family. You work closely with team colleagues in the sub-network, who can also represent you if needed. The position is located in the sub-network, to which you report directly. In this environment, you can function as a coach for less experienced colleagues and share your knowledge, while continuously expanding and developing your own skills.

Responsibilities | What You Will Expect

  • In your role as Senior Quality Manager Infrastructure Partnering, you are responsible for ensuring that the requirements of the mQMS (modular quality management system) are effectively implemented in the qualification and validation and during the entire lifecycle.
  • You are responsible for the review of GxP-relevant qualification and validation documents as well as technical changes during the project phase.
  • In the context of projects, you support our partners in the creation of functional risk analyses (FMEA).
  • You ensure that deviations in the context of qualification and validation are evaluated with the involved functions and, if necessary, processed according to the IRM process.
  • Increase business results and customer benefits: You are responsible for the independent implementation of activities necessary to achieve the Q&R goals. This includes the independent creation and review of documents as well as the conduct of technical reviews. You address arising problems, develop solutions and implement them to ensure compliance with regulations. You act as a recognized, internal expert in your discipline.
  • Drive the work of the network and break down silos: You work daily with minimal to no supervision, make decisions with courage, and initiate activities independently. You identify, initiate, and implement process improvements. You lead projects and working groups or actively contribute your skills and participate in solving unique, function- or network-wide problems.
  • Empower and enable the network: You build and maintain strong partnerships to ensure the strategic direction. As an advocate of "Engrained Quality," you support a culture of continuous improvement.
  • Enable "new ways of working": You live agile behavior, our culture and mindsets. Your actions directly contribute to achieving our ten-year goals, such as doubling patient access to innovative diagnostic solutions and improving the lives of patients through the "OneRoche Approach".

Qualifications | What You Bring

  • You have a completed degree in process engineering, automation, chemistry, biotechnology or a related field.
  • You have more than five years of professional experience in a comparable field.
  • You have worked in more than one function within quality management and ideally also outside of quality management.
  • You have very good English skills.

Application documents

Please upload your current resume.

We look forward to your application!

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Ops Quality Senior Quality Partner
Mannheim, Baden-Württemberg, Germany
Operations
About Roche
A global healthcare company that specializes in pharmaceuticals and diagnostics to improve patient outcomes and advance medical science.