• , US

Company:  Confidential

Job Title: Director, Clinical Quality Assurance

Job Number: 74816

Location: , US

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

Application Deadline: 2024-03-25

 

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