Clinical Quality Management

2 months ago


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


Key Duties AndResponsibilities

  • Lead Quality Event Managementactivities related to the investigation, root cause analysis anddevelopment of corrective action/ preventive action plans for GCOassigned events, including unplanned deviations, corrective/preventive actions and effectiveness checks ensuring timelines forclosure are met.
  • Ensure visibility to andmanage awareness of any noted deviations, issues or deficiencies byescalating to management.
  • Identifies and solvescomplex technical and operational problems, leveraging theappropriate resources.
  • Generate and analyzeweekly, monthly and quarterly metrics.
  • Providesstrategic input to solve complex problems while exercising judgmentusing multiple sources of information.
  • Developsolutions that fully address business needs and align standards(Proficient)
  • Communicate clear and convincingopinions, ideas, and positions, tailored to the audience, in apoised, confident, and convincing manner(Proficient)
  • Ensure all activities align withcorporate requirements for training
  • Serve astechnical resource for audits/inspections asneeded
  • Ensure consistency in processesthroughout all functions in Global Clinical Operations

Knowledge AndSkills

  • Advanced understanding of GCP, CFRand ICH guidelines
  • Significant experienceparticipating in clinical quality activities and in-depth knowledgeof clinical operations
  • Possess strong criticalthinking skills with a focus on inspectionreadiness.
  • Significant experience withinvestigations, root cause analysis and corrective action andpreventive action plan development.
  • Leverageknowledge of organizational goals and interdependencies with otherfunctional areas to drive success.
  • Demonstratedattention to detail, accuracy, excellent review and analyticalskills in a fast-paced environment.
  • Resultsoriented
  • Significant experience with guidingand coaching employees
  • Excellent interpersonalskills with an ability to effectively work and problem solve withina multidisciplinary team
  • Excellent verbal andwritten communication and presentationskills
  • May lead a department or sub-departmentinitiative.
  • Express views with conviction thatgains support from stakeholders, even when they may have adifferent opinion or when the subject matter isunfamiliar.

Education AndExperience

  • Bachelor degree in a life sciencesdiscipline
  • Typically requires 8 years ofexperience, or the equivalent combination of education andexperience, in the biopharmaceuticalindustry


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