Director Of Clinical Quality Assurance

Director of Clinical Quality Assurance Overview

• The Director of Clinical Quality Assurance oversees the North America Clinical Quality Assurance strategy, ensuring compliance with global regulations and guidelines.
• Lead audit and inspection management, ensuring adherence to Good Clinical Practice (GCP) standards and organizational policies.
• Collaborate with cross-functional teams to enhance quality management systems and ensure regulatory compliance.
• Provide expertise in therapeutic areas such as neuroscience and oncology, translating protocol objectives into actionable quality activities.
• Develop and implement skill-building initiatives for Clinical Quality Assurance staff, adapting to evolving technologies.
• Support sponsor health authority inspections, ensuring readiness and compliance of clinical facilities and study sites.
• Maintain Quality's independence and authority while effectively collaborating with senior stakeholders in high-pressure situations.
• Offer remote work flexibility with occasional in-office presence for audits and critical inspection activities.

Director of Clinical Quality Assurance Key Responsibilities & Duties

• Conduct audits independently, ensuring adherence to clinical quality standards and regulatory requirements.
• Oversee Clinical Quality Assurance audits of study sites, vendors, documents, and internal processes.
• Facilitate sponsor inspections of global clinical facilities and study sites, ensuring compliance and readiness.
• Provide training and development opportunities for Clinical Quality Assurance staff to enhance their capabilities.
• Collaborate with cross-functional teams to implement quality management systems and maintain compliance.
• Ensure adherence to international regulatory standards and guidelines for clinical trials.
• Develop comprehensive reports and analyses based on audit findings and inspection outcomes.
• Travel as required to conduct audits and support inspection management activities.

Director of Clinical Quality Assurance Job Requirements

• Bachelor's degree in a relevant discipline; advanced degree preferred.
• Minimum 12 years of experience in clinical research, operations, or related fields.
• Strong knowledge of neuroscience and oncology therapeutic areas.
• 5+ years of experience in Good Clinical Practice (GCP) auditing.
• Expertise in inspection management and compliance with international regulatory standards.
• Proficiency in data integrity controls and systems quality for clinical areas.
• Ability to travel approximately 15% for audits and inspections.
• Strong analytical skills and ability to produce detailed audit reports.