Covance

  • Head of Quality, SEA & ANZ - Good Clinical Practice (GCP)

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

    Are you ready to explore an exciting opportunity to provide strategic and operational leadership for our Quality Assurance team in the Asia Pacific region? You will work in partnership with global senior leaders to drive excellence in clinical research and lead a team of highly skilled auditors to develop and execute audit programs for the region. If you are a high performer looking for your next challenge let's talk.

     

    Covance in Asia Pacific has an outstanding reputation for quality. You will join an exceptionally talented team of industry leading professionals that together will assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfil client and Covance requirements.

     

    To do well in this job you will:

    • Be responsible for the execution of the Quality Assurance regional audit program and the oversight/direction of regional auditors, assuring alignment with global quality strategies, optimal utilization of audit resources, and of reporting of results/outcomes, ensuring adequacy of corrective and preventive actions (CAPA) to address issues, trending of audit findings and supporting continual quality improvement.
    • Be required to work with all levels of internal regional functional management (up to and including Executive Leaders), to drive the culture of quality. 
    • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfil client and Covance requirements.

    Tempted in moving your career to a growing organisation? If so, please apply today!

     

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

     

    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:

      • Resource management skills and ability to inspire effective teamwork and motivate staff
      • Excellent technical knowledge, understanding an experience applying ICH/FDA / Good Clinical Practices
      • Strong analytical skills
      • Excellent oral, written and presentation skills
      • Excellent planning and organizational skills
      • Proven interpersonal skills
      • Demonstrated ability to handle multiple competing priorities
      • Ability to function as a member of a global clinical team
      • Proven ability to understand, analyse and communicate the impact of global regulatory issues affecting the drug development process

    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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