Project Quality & Risk Manager
ICH GCP
Taiwan
5天前

Serve as primary project quality expert, point of contact and support to project team leadership throughout the project. Manage the Quality Evaluation (QE) workflow.

Communicate results to the project team (PL, FLs). Provide support with quality issue management, audits and inspections, and project quality and risk consultancy as required.

Assess operational execution using a risk-based approach to verify adherence to standards and assist with remediation when required.

Facilitate quality related interactions with clients. Mentor Project Quality & Risk Leads as assigned.

Education :

  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
  • Master’s degree in a science, technology or industry related discipline, preferred
  • Knowledge and Experience :

  • Relevant experience (e.g., in the pharmaceutical or CRO industry).
  • English proficiency (written and oral English)
  • Skills :

  • Excellent interpersonal, verbal and written communication skills
  • Client focused approach to work
  • Substantial clinical trials experience
  • Leadership and / or project management skills and experience
  • Ability to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs)
  • Ability to act as the main quality contact with clients
  • Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
  • Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
  • IT literate : experienced with Microsoft based applications and general knowledge of personal computer functions
  • Ability to travel approximately 30%-50%
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