Clinical Quality Management

4 weeks ago


Dubai, United Arab Emirates myGwork - LGBTQ+ Business Community Full time


Key Duties And Responsibilities

  • Lead Quality Event Management activities related to the investigation, root cause analysis and development of corrective action/ preventive action plans for GCO assigned events, including unplanned deviations, corrective/ preventive actions and effectiveness checks ensuring timelines for closure are met.
  • Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management.
  • Identifies and solves complex technical and operational problems, leveraging the appropriate resources.
  • Generate and analyze weekly, monthly and quarterly metrics.
  • Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.
  • Develop solutions that fully address business needs and align standards (Proficient)
  • Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner (Proficient)
  • Ensure all activities align with corporate requirements for training
  • Serve as technical resource for audits/inspections as needed
  • Ensure consistency in processes throughout all functions in Global Clinical Operations

Knowledge And Skills

  • Advanced understanding of GCP, CFR and ICH guidelines
  • Significant experience participating in clinical quality activities and in-depth knowledge of clinical operations
  • Possess strong critical thinking skills with a focus on inspection readiness.
  • Significant experience with investigations, root cause analysis and corrective action and preventive action plan development.
  • Leverage knowledge of organizational goals and interdependencies with other functional areas to drive success.
  • Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fast-paced environment.
  • Results oriented
  • Significant experience with guiding and coaching employees
  • Excellent interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
  • Excellent verbal and written communication and presentation skills
  • May lead a department or sub-department initiative.
  • Express views with conviction that gains support from stakeholders, even when they may have a different opinion or when the subject matter is unfamiliar.

Education And Experience

  • Bachelor degree in a life sciences discipline
  • Typically requires 8 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry


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