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Asso. Manager, Site Quality & Compliance

About Human Pharmaceutical Business

With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.

 

Job Responsibilities

  • As a member of Clinical Development & Operations(CDO) Site Quality & Compliance, be responsible for the site quality and compliance initiatives in assigned area, this will include but not limited to:
    • Implement global and local site quality and compliance initiatives
    • Participate, support and actively contributes to continuous process improvements, knowledge management and training management within CDO, when applicable
    • Work closely with Quality Medicine(QM) team to identify areas for site quality and compliance improvement and discuss suggestions; support CDO to plan /strategize site quality and compliance initiatives and ensure implementation
  • Inspection and audit readiness
  • Work with QM and other stakeholders in Medicine to support CTMs and CRAs during a site inspection or sponsor inspection; furthermore, coordinate certain activities on behalf of clinical operations, if required and appropriate.

 

Job Requirements

  • Minimum 5 years' experience in clinical operations, including at least 1 year quality relevant experience and experience with inspection and audit
  • Project management experience or equivalence will be a plus
  • Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical trials
  • Strong Quality sense and proven records of high quality standard
  • Good communication and organization skills
  • Fluent in reading, writing and speaking English

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