Process Excellence and Digital QMS Quality Partner

hace 3 semanas

Sant Cugat del Vallès, España Roche A tiempo completo

The Position

Who We Are

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world.

That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.

We do this today to build a better tomorrow.

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.

Role Purpose

As a Digital QMS Quality Partner you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the Diagnostic Commitments.

You are responsible for building and developing your capabilities to contribute more to the team, customers, and patients.

You apply new approaches to improving your work to enhance established processes, reduce costs, or mitigate significant compliance issues within your area of influence.

You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle.

You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

You will be responsible to:

  1. Contribute to implement and maintain the Quality Management System for Roche Information Solutions (RIS), which consists of a portfolio of standalone software for medical or health purposes.
  2. Quality management of documents, processes, and support for audits and certifications applicable to RIS products.
  3. Contribute to compliance activities required by regulations and standards for In-Vitro Diagnostics and Medical Device Manufacturers of standalone software products to assure a sustainable state of compliance.
  4. Participate in continuous improvement, integration, harmonization of the Quality Management System, Management Review preparation, key performance indicators, Audit and Inspection readiness, and Change Management.
  5. Participate in regional or global cross-functional meetings/initiatives where it may take a leading role.
  6. Interface with colleagues from Quality, Regulatory, including auditing and post-market Chapters, R&D, Supplier Quality, and Training Chapter to perform the job.
  7. Build and maintain strong partnerships with colleagues and business partners to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.

Additional tasks:

  1. Can coach and train quality professionals with less experience and provide guidance.
  2. Collaborate to audit readiness for internal and external audits.
  3. Act as a learning expert in defining and maintaining all required training according to the roles and responsibilities.
  4. Support in change control methodology and documentation.
  5. Support investigation or documentation of non-conformities or CAPA.
  6. Identifying and escalating issues as they arise and able to provide adequate solutions.

What else do you have in your toolbox:

  1. 2-5 years of working experience
  2. Bachelor’s/Master's degree in Life Science, Data Science, or related subject or equivalent experience.
  3. Knowledge of Regulations and Quality Management Systems in Health Care (Pharmaceutical or Medical Devices).
  4. Specific knowledge on ISO13485, ISO14971, IEC62304, IEC 82304, and legislation for software as medical device will be an advantage.
  5. Able to initiate daily activities independently with limited guidance or supervision.
  6. Good communication skills.
  7. Has courage to make decisions within the scope of responsibility.
  8. Is able to drive innovation within their own area of influence.
  9. Is able to contribute by participating in large/global cross-functional or cross-chapter squads where it may take a leading role.
  10. Proficient user of IT tools.
  11. Advanced level of English. Other languages are an advantage.

Locations:

We offer a hybrid model with a lot of flexibility between the Sant Cugat del Valles office and the home office.

What else:

This role offers a competitive salary, plus an excellent benefits package that includes (among others):

  • Fascinating opportunities for your professional growth.
  • Additional holidays per labor agreement.
  • Wide range of options and platforms for learning and development.
  • Agile and flexible working policy, working from home.
  • An exceptional and modern office space (canteen, parking, and free coffee).
  • Private medical insurance.
  • Pension plan.
  • Life insurance.
  • Roche stock options.

Please check the following link to know more about our benefits.

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.

At Roche, diversity and inclusion are essential values for our success. We have a special interest in integrating people with disabilities into our teams.

If you have a disability, for us it is a plus, and we have special benefits for you: Go ahead and join us

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