Q-711 - Process Excellence And Digital Qms Quality Partner - Global Quality & Regulatory Roche [...]

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 :

• 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.
• Quality management of documents, processes, and support for audits and certifications applicable to RIS products.
• 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.
• Participate in continuous improvement, integration, harmonization of the Quality Management System, Management Review preparation, key performance indicators, Audit and Inspection readiness, and Change Management.
• Participate in regional or global cross-functional meetings / initiatives where it may take a leading role.
• Interface with colleagues from Quality, Regulatory, including auditing and post-market Chapters, R&D, Supplier Quality, and Training Chapter to perform the job.

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 :

Can coach and train quality professionals with less experience and provide guidance. Collaborate to audit readiness for internal and external audits.#J-18808-Ljbffr