WuXi AppTec

  • Global Compliance Officer

    Job Locations CN
    Job ID
    2019-4682
  • Overview

    Company introduction:

    WuXi Biologics is a world-class CMO with the most comprehensive capability and technology platform serving clients globally in the biopharmaceutical and health care industries from discovery to commercialization.  The company is publically listed in Hong Kong, with a market capital of $13 billion.  Our dream is to ensure “every drug can be made and every disease can be treated” to become a reality for both WuXi Biologics and our clients/strategic partners.  The company has sites/offices in China, US, EU, Asia and Israel.  The company currently has 4,000 employees, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.

     

    With the rapid development of the business, WuXi Biologics China is looking for talent at all levels of experience.  We have positions which require from 0 – 20 years of experience and can be from Entry level Scientist to senior Director. These are great opportunities to join our company in China as we continue to build our capacity and technology platform so that “every drug can be made and every disease can be treated”.

    Responsibilities

    • Establish the CQO Office, to define mission and scope of the global operations to ensure quality compliance and quality system.
    • Serve as Head of CQO Office, managing global quality and administrative operations to include Quality Department budget planning and staff performance evaluation.
    • Provide guidance and lead continuous improvements of Quality System.
    • Manage internal audit programs and external audits to ensure Quality compliance at all WuXi Biologics sites. 
    • Oversee global computer system qualification and validation programs.
    • Support regulatory inspections by national and international regulators.
    • Work with senior leadership in QA, QC, RA and training to develop global development strategy
    • Recruit, develop and train talents to meet business need.

    Qualifications

    • Major in Chemistry, Biochemistry, Biology, Pharmaceutical, Biological Engineering or related field.
    • 15+ years of experiences in biopharmaceutical industry, including 5+ years of experiences in Quality Management
    • Knowledge in FDA/EMA/China GMP regulations, Pharmacopoeia and ICH guidelines
    • Experience in GMP Compliance
    • Excellent oral and written communication skills in both English and Chinese.

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

     

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    https://careers-wuxiapptec.icims.com/connect

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