IT Quality Manager（Supervisor）

This position resides in the Suzhou site and is responsible to ensure the compliance of systems in IT responsibility for Roche Diagnostics Suzhou. The compliance scope includes GxP regulated computerized systems, Site IT security contact, IT risk management, Data privacy and IT operational process for non-GxP system life cycle, primarily for Roche Diagnostics Suzhou. The incumbent will also be part of the virtual team in supporting the Global IT Quality.

?    Liaise with global IT quality and RDSZ local quality to be the owner of local IT Quality Policies (QAP), quality related operation process (SOP), tools and standards to the stakeholders (e.g. Business, Global Functions, Global Site IT)
?    Develop/maintain quality procedures along the life cycle of in-scope computerized systems
?    Keep compliance information in ITSM tool updated,, Site IT risk register and associated mitigation activities
?    Support project activities as IT Quality Assurance, in particular for local GxP IT projects
?    Support IT lifecycle processes such as change control and document management
?    Provide training related to IT systems quality and compliance
?    Support Site Business, when needed, as extension of Site Quality and Global IT Quality, for the topic of Data retention, Data Privacy & Electronic Change management process

Main  Tasks & Responsibilities:

IT quality management for IT projects
?    Act as the single point of IT quality for all projects assigned, typical tasks include managing project risks in GxP area, developing IT system validation plan, reviewing IT system validation results
?    Act as a project team member from the start of the project, to define relevant project adaptation of  IT governance processes such as PMM,CSV and CSA; Understand scope, complexity and delivery approach of the project to effectively influence the IT quality best practices used in this project
?    Support tailoring of project deliverables and the PMM paths according to the selected route, advising Ｏn the number of documents and the content material to be produced
?    Escalate nonconformance identified during project which may risk the quality of the project

Ensure that internal and external standards are met
?    Provide advice Ｏn the current standards such as PMM, documentation standards, Infrastructure Qualification, Roche CSV policy and directive, system risk assessment, data privacy, GxP assessment, test documentation and change management
?    Support RDSZ local quality team to review and approve respective IT areas within local business QMS, and stay flexible to be the extension of local quality team when the incumbent’s qualification applies
?    Act as the internal auditor, perform Internal audit based Ｏn the approved site internal audit plan
?    Provide training / support to the team members Ｏn document standards and use of templates when required
?    Act as IT quality SME for CSV related topics during ISO 13485 and cGMP audit In the quality document controller role, to ensure quality of all formal IT documents
?    Support creation/review/approval of life cycle documents using the established templates in PMM
?    Support creation of GxP related IT governance SOP following global/local templates
?    Manage changes in Service Now in the role of IT Quality