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Clinical Quality Management Specialist

4 weeks ago

Dubai, Dubai, United Arab Emirates myGwork - LGBTQ+ Business Community Full time
Job Title: Clinical Quality Management

At myGwork - LGBTQ+ Business Community, we are seeking a highly skilled Clinical Quality Management professional to join our team. As a key member of our Global Clinical Operations department, you will play a critical role in ensuring the highest standards of quality and compliance in our clinical operations.

Key Responsibilities:
  • Lead Quality Event Management: Investigate, analyze, and develop corrective action/preventive action plans for assigned events, ensuring timely closure and compliance with regulatory requirements.
  • Ensure Visibility and Awareness: Escalate noted deviations, issues, or deficiencies to management, ensuring prompt attention and resolution.
  • Identify and Solve Complex Problems: Leverage resources to resolve technical and operational issues, exercising judgment and strategic thinking.
  • Generate and Analyze Metrics: Develop and track weekly, monthly, and quarterly metrics to measure quality and compliance performance.
  • Provide Strategic Input: Contribute to solving complex problems, exercising judgment and using multiple sources of information.
  • Develop Solutions: Create solutions that address business needs and align with corporate standards.
  • Communicate Effectively: Communicate clear and convincing opinions, ideas, and positions to various audiences.
  • Ensure Training and Audit Readiness: Ensure all activities align with corporate training requirements and prepare for audits/inspections as needed.
Requirements:
  • Advanced Knowledge: Advanced understanding of GCP, CFR, and ICH guidelines.
  • Significant Experience: Significant experience participating in clinical quality activities and in-depth knowledge of clinical operations.
  • Critical Thinking: Strong critical thinking skills with a focus on inspection readiness.
  • Investigation and Analysis: Significant experience in investigations, root cause analysis, and corrective action/preventive action plan development.
  • Leadership and Coaching: Significant experience guiding and coaching employees.
  • Interpersonal and Communication Skills: Excellent interpersonal and communication skills with the ability to work effectively in a multidisciplinary team.
  • Education and Experience: Bachelor's degree in a life sciences discipline and typically 8 years of experience in the biopharmaceutical industry.