Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Job Summary:

The job holder ensures to meet / perform

GeneralSystem ManagementProcess ManagementQuality ComplianceSafety, Health & EnvironmentLeadershipContinuous Improvement and Innovation

Main Tasks & Responsibilities:

General

Plan, organize and monitor routine tasks and activities within group Report activities and critical issues to superiors in a timely mannerSupport and/or implement manufacturing, quality and business initiatives in compliance with local authority requirementsManage and optimize communication within QC and with external functions within RDSZ in order to ensure a smooth cooperation

System management

Document system

Ensure the compliance of QC document system to meet related product and quality system requirements.

QC operational system

As site key user, support the implementation of SAP, LIMS and other digital system building up and launchingBesides SAP QM module, also involve in other SAP modules which are related to business needs, such as NC, CAPA, ECR (Change), DVS (validation document management) etc.Coordinate the roll out of QC digital operation, such as QC dashboard, paperless etc.

Process management

Coordinate the analysis of end-to-end business process within QC to set up reasonable process for all activities.Responsible for organizing and coordinating cross functions to align process connection.Continue to monitor process and updated as necessaryLead process optimization in compliance, integrity, reasonability and usability.Responsible for organizing CI and Lean project to improve efficiency and reduce cost within QC.

Quality compliance

Ensure the alignment with internal specifications and the external regulatory requirement such as ISO 13485 and China Medical Device GMPCoordinate new/changed regulation assessment in QCInvolve in internal or external quality audit as QC representativeParticipate in product issue investigation internally or externally in technical discussionSupport the establishment of the training matrix/needsFacilitate the preparation of QC registration documentsExecute the training related to the responsible areas and be mentor of new employees in the department

Safety, Health & Environment

Fulfill all applicable SHE requirements to comply with corporate group policy and local regulations

Leadership

Mentor team membersSolve the problems escalated from team membersSupport manager for team activities

Other tasks assigned by leader

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.