Covance

  • Associate Director, Quality Assurance

    Job Location(s) CN-Shanghai | CN-Beijing | CN-Dalian | TW-Taipei City | SG-Singapore
    Job Number
    2018-18699
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

                 Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.

    • Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
    • Manage allocation of QA&C staff within local region to complete the required audits and fulfill staff utilization/achievement of QA&C targets
    • Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
    • Provide local /regional leadership and line management as required

    Education/Qualifications

     

    • Minimum Required:
    • University/college degree, BA/BS (life science preferred) or equivalent experience Preferred
    • Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience

    Competencies Required:

      • Excellent technical knowledge, understanding and experience in applying ICH/FDA/Good Clinical Practices
      • Excellent oral, written and presentation skills
      • Excellent planning and organizational skills
      • Proven interpersonal skills
      • Demonstrated ability to handle multiple competing priorities across clinical operating units
      • Ability to inspire effective teamwork and motivate staff within a matrix system
      • Ability to function as a member of a global clinical team
      • Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
      • Financial understanding of global clinical development budgets

     

    Experience

    Minimum Required:

    4 years’ experience in Clinical Quality Assurance, preferably with GCP experience

    7 years’ experience in other professional roles within pharmaceutical/CRO environment.. Other required work-related experiences

    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organization

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