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 operational leadership for our Quality Assurance team in the Asia Pacific region? You will work in partnership with other senior leaders and drive organizational excellence in Good Clinical Practice (GCP) by establishing goals (business, client & quality) to ensure operational excellence. 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:

    • 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

     

    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:

      • 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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