Clinical Quality Management

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