PRAHS

  • Manager of Quality Assurance

    Job Locations (All) | China-Beijing | China-Shanghai
    Posted Date 6 months ago(4/23/2018 8:20 AM)
    ID
    2018-45692
  • Overview

    Location: Beijing, Shanghai

     

    As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

     

    At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

     

    At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 13,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

    Responsibilities

    • Participates in the selection, hiring and training of new QA staff.
    • May functionally manage 1-15 Auditors and/or manage other managers
    • Leads QA auditors’ team by providing clear team / individual goals and expectations and ensuring that each member of the auditing staff understands her/his responsibility to know and follow all SOPs and corporate policies
    • Contributes to the development and ensures implementation of the Quality Assurance operating plan
    • Makes recommendations for and assist in the development of Quality Assurance policies, procedures and practices. Maintains awareness of new system implementations, Quality Assurance and technological advancements.

    Qualifications

    You are:

    Detail focused, adaptable and a communicative leader

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    7+ years’ experience with auditing, compliance, and SOP development required, 2 years experience direct management of staff.

    • Compliance or auditing management experience required.
    • Must have thorough understanding of GCP and EC and/or US regulations
    • Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
    • Read, write and speak fluent English;fluent in host country language required.  Fluency in other languages is a plus. 

     

     



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