Covance Quality Control Manager in Taipei City, Taiwan

Job Overview

We are hiring Quality Manager in Taiwan or Hong Kong, the role will base in our client's office to support quality tasks.

  • Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating ProceduresandICH Guidelines and GCP

  • Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country/US region at the Client level according to the Client Standard Operating ProceduresandICH Guidelines and GCP

  • Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region

  • Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement.

  • CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented

  • The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures

  • This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client

Education/Qualifications

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology

Experience

  • Minimum of six-eight (6-8) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)

  • Preferred auditing experience

  • Deep knowledge and understanding of Clinical Trial processes and quality management tools

  • Demonstrated experience leading cross-functional teams of business professional

  • Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results

  • Excellent site monitoring skills

  • Excellent study site management skills

  • Ability to work with minimal supervision

  • Good planning and organization skills

  • Good computer skills with good working knowledge of a range of computer packages

  • Excellent verbal and written communication skills

  • Ability to train and supervise junior staff

  • Ability to resolve project-related problems and prioritizes workload for self and team

  • Ability to work within a project team

  • Works efficiently and effectively in a matrix environment

Job Number 2018-25577

Job Category Quality Assurance

Position Type Full-Time

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