Senior Director/Executive Director Of Clinical Quality

Overview

• Lead the Clinical Quality Assurance team, ensuring adherence to Good Clinical Practices (GCP) and regulatory standards across clinical programs.
• Oversee auditing processes, including vendor qualification, site audits, and internal system evaluations to ensure compliance and quality.
• Collaborate with cross-functional teams to address deviations, perform root cause analyses, and implement corrective actions effectively.
• Develop and execute comprehensive audit plans tailored to specific clinical studies and regulatory requirements.
• Provide strategic guidance and training for clinical investigator meetings and regulatory inspection preparedness.
• Maintain and enhance tracking systems for audit activities, delivering actionable metrics and insights to management.
• Ensure audit reports meet high standards and offer actionable recommendations for compliance and operational improvement.
• Travel as needed to conduct audits and collaborate with clinical teams to uphold quality standards.

Key Responsibilities & Duties

• Plan, schedule, and oversee GCP audit services for clinical development activities, ensuring regulatory compliance.
• Review and evaluate audit reports, ensuring alignment with SOPs and regulatory guidelines.
• Collaborate with clinical teams to resolve audit findings and implement corrective and preventive actions.
• Conduct GLP and GCP vendor audits, ensuring adherence to industry best practices and standards.
• Provide expert consultation on vendor performance issues and develop effective corrective action plans.
• Supervise remote vendor audits, ensuring thorough follow-up actions and compliance tracking.
• Maintain robust audit tracking systems and deliver periodic metrics and reports for management review.
• Assist in regulatory inspections and provide specialized GCP training to teams as required.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or a related field is required.
• Minimum of 15 years of experience in clinical auditing and compliance roles, with executive-level expertise.
• Proficiency in GCP auditing, including investigational sites, clinical reports, and vendor assessments.
• Comprehensive knowledge of US and ICH GCP regulations and guidelines.
• Experience with clinical safety and trial management systems such as ARISg and TrackWise.
• Exceptional interpersonal, communication, and organizational skills to manage complex projects.
• Proven ability to handle competing timelines and deliver results under pressure.
• Willingness to travel 40-60% for audits and collaborative engagements.