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The Position

Overview

Represents design quality in product transfer/development to achieve sustainable compliance of projects.Provides design quality support with a pro-active, business solution oriented approach, while collaboratively being involved in the generation, review deliverables during product transfer/development.Proactively related regulation assessment for design and development part from quality perspective.Ensures that any design quality issues that may jeopardize the regulatory status of the projects and products in their work area are handled with the necessary priority and urgency.Ensure that the process is complies with the requirements of European, US, China and International cGMP regulations and the requirements from Roche Global Standard Process or Divisional Quality Standard.

The What

Perform activities as required to meet Q&R goals and objectives independently. Able to identify improvements and implement with collaboration from supervisor. Navigates in complex situations by applying a diverse skillset.Prepare documentation for and participate in audits as applicable.Document authoring and review as required to support changes.  Performs technical reviews, as applicable.  May require collaboration with supervisor on technically complex technical reviews independently.Complete all required training in learning solution.Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.Ability to work day to day with minimal to no supervision to correctly complete daily scheduled and unscheduled activities.  Initiates activities independently and initiates interactions across departments as applicable. Initiates daily activities independently. Has courage to make decisions even outside of scope/comfort zone. Is decisive and does not procrastinate on decisions; develop solutions and presents both issues and solutions to supervisor.Identify, Initiate, facilitate, participate and implement process improvements to meet business needs.  Able to link responsibilities with both site and Global Quality and Regulatory.  Drive innovation across the local organization/site.

The How

Know and follow the We@Roche Diagnostics Dimensions and Roche Core Competencies. Adopts and adheres to the Leadership Commitments. Accountable for meeting commitments. Is flexible able to shift priorities while balancing commitments and daily work requirements, independently.   Seeks candid feedback on his or her performance and acts on it.  Recognizes the contributions of teammates and peers.  Establishes strong collaborative relationships inter-departmentally and across the sites and leverages these connections to achieve our key results.  Identifies personal goals and actively manages her or his career to pursue personal goals and priorities independently.

The Impact:

We employ talented people and expect great things from them. Contributions are delivered in a way that lives up to our commitments to each other and the We@Roche Diagnostic Commitments. Build and develop your capabilities to contribute more to the team, local and global organization, customers and patients. Apply new ways of enhancing your work to drive approaches that increase productivity, reduce costs or mitigate significant compliance issues within your area of influence as well as across sites and all of the global functions. Works 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. Push the boundaries to enable, develop and drive smart, risk-based compliant processes that result in quick and efficient innovation.

Main Tasks & Responsibilities:

Support to maintain quality management related procedure in design and development and provide quality opinion from compliance view.Participates in the reviewing of deliverables and milestone review meeting, and present as a quality representative for new development/product transfer.Supports external and/or internal audits and inspections based on the business needs.Tracking and interpreting external requirements regarding design and development aspect and making recommendations for implementation.Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations.Deal with complex problems in diverse range of tasks.Coach junior employee.Other tasks assigned by line manager.

Qualification & Experience:

A Bachelor’s degree in Life Science, pharmaceutical engineering or related subject.Competent with routine application of MS Office.At least five (5) years in the Medical Device/Pharma/Biopharmaceutical industry.Has worked in more than one function within quality management and may have worked outside of Quality Management.  Can managing highly complex and/or global projects, or equivalent experience.Knowledge of the European, US, China and International cGMP regulations.Good in communication and report writing in Chinese and English.

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.