Company Background:
Our client is a research-based, growth-oriented global enterprise with core competencies in the fields of health care, nutrition and innovative materials.

Position purpose:

As a member of the O&I China team the incumbent must ensure that the IT systems and processes which are used for BHC China companies are in compliance in respect to Internal and external requirements such as:

• GxP regulations for China as well as GxP related Bayer guidelines
• The Group directives, guidelines and regulations
• BHC guidelines and regulations
• China regulations and Laws for IT systems
• Other external regulations (e.g. ISO certificate)

Major tasks and responsibilities of position:

• He/she is responsible to set-up and to maintain a framework that all relevant IT systems used by BHC China are in compliance with the GxP regulations in close cooperation with the PS QA/QC functions. He/she is responsible to develop and maintain needed guidelines and standard operation procedures to fulfill GxP requirements.
• He/she is responsible to monitor the GxP compliance and to assure that appropriate actions are defined in case of deficiencies and monitors the execution of these activities
• He/she supports the local QA/QC Manager in all IT related GxP activities and acts as the contact person for all relevant IT related GxP topics of the company
• He/she is responsible to set-up and to execute appropriate General IS Controls (GISC) processes as mandated by the Bayer Group Internal Control System (ICS). He/she is responsible to monitor the compliance (e.g. regarding Bayer directives 1775, 1915 and 1435) and to assure that appropriate actions are defined in case of deficiencies and monitors the execution of these activities. He/she manages and directs all related activities, e.g. development and management of authorizations and user administration.
• He/she supports the local ICS Manager in all ICS audit activities related to GISC processes and 1775 compliance and the contact person for all relevant GISC and 1775 directive topics of the company. He/she is responsible to prepare and maintain the IT related part of the Self Assessment Questionnaire in close cooperation with the Head of O&I and the local ICS manager
• He/she ensures appropriate training of O&I staff and users regarding compliance topics.
• He/she supports IT systems and processes audits by internal or external inspectors.
• He/she reports periodically the local GISC and 1775 compliance Status to the local ICS Manager and Head of O&I Greater China as well as the local GxP status related to IT to the QA/QC Managers of PS and the Head of O&I Greater China. He/She also reports periodically the local IT compliance (e.g. 1435, 1915 ...etc) Status to the Head of O&I Greater China. 

Qualifications:

• Minimum of three years of overall experience in business information systems, along with a university or advanced degree, preferably in a business discipline or computer science.
• Strong experience and expert knowledge in the business area he/she is supporting.
• A high level of Healthcare industry knowledge is also desired.  The effective performance of this job requires the incumbent to be or to become familiar with the BHC China's business processes and to have a comprehensive knowledge of BHC´s IT system landscape and the Global O&I Organization
• The IT skills comprise standards and systems, modeling techniques, development methodology(s), business analysis/design concepts as well as project management skills.
• Profound knowledge of QM and Validation standards (ISO9001,GxP, ITIL, ICS ,etc.)
• Very good knowledge of the compliance requirements as well as the business processes
• Sensitivity to people with varying backgrounds is necessary, since the incumbent must have contact with all levels of people with different professional backgrounds.
• The incumbent must be fluent in Chinese and English (Spoken and written)