• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Director, Clinical Quality Assurance

Job Number: 34062

Location:

Job Description

We are seeking a dynamic and results-driven Director of Clinical Quality Assurance (QA) to join our team. This key leadership role will be responsible for establishing and maintaining a robust QA system for our clinical operations, ensuring compliance with regulatory standards, and driving a culture of quality throughout the organization. 

Responsibilities

  • Head Clinical QA and ensure a culture of continuous improvement
  • Ensure clinical activities adhere to GCP regulations, guidelines, and industry standards
  • Develop and maintain clinical QA standards, policies, and procedures
  • Perform QA review and approval of clinical documents
  • Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures
  • Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization
  • Establish and report key quality metrics to monitor performance and drive improvements in GCP compliance and drive quality enhancement initiatives
  • Lead the GCP vendor qualification program and activities including audits, assessments, and quality agreement negotiation to ensure quality of clinical trial services
  • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness
  • Collaborate with cross-functional teams to ensure the quality of clinical data and documentation
  • Develop and deliver training on GCP topics, quality standards, and best practices
  • Ensure personnel are adequately trained in GCP requirements and quality procedures
  • Provide guidance and support to teams to enhance their understanding and implementation of quality standards
  • Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety
  • Lead GCP inspection readiness activities to support regulatory authority inspections

Required Skills

 

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