Senior Project Quality & Risk Lead
ICH GCP
Canada
1d ago

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 Lead, as assigned.

Qualifications :

  • Excellent interpersonal, verbal and written communication skills.
  • Client focused approach to work.
  • Substantial clinical trials experience.
  • Leadership and / or project management skills.
  • Able to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs).
  • Able to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning.
  • Able to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills.
  • Able 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.
  • Able to travel approximately 30% 50%.
  • Education :

  • Educated to the degree level (Life Sciences, Pharmacy, Technology)
  • 5+ years in Quality Management
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