Senior Director/Executive Director Of Clinical Quality

Overview

• Lead the Clinical Quality Assurance team, ensuring compliance with Good Clinical Practices (GCP) and regulatory guidelines.
• Oversee auditing services for clinical programs, including vendor qualification, site audits, and internal system assessments.
• Collaborate with cross-functional teams to manage deviations, root cause analysis, and corrective action plans.
• Develop and implement study-specific audit plans to support clinical development activities.
• Ensure audit reports meet standards and provide recommendations for improvement and compliance.
• Provide training for clinical investigator meetings and support regulatory inspections.
• Maintain tracking systems for audit activities and provide periodic metrics for review.
• Travel as required to conduct audits and collaborate with clinical teams.

Key Responsibilities & Duties

• Schedule, conduct, and supervise GCP audit services for clinical development activities.
• Review and assess audit reports, ensuring compliance with SOPs and regulatory guidelines.
• Collaborate with clinical teams to resolve audit findings and implement corrective actions.
• Plan and conduct GLP and GCP vendor audits, ensuring adherence to best practices.
• Provide consultation on vendor performance issues and develop corrective action plans.
• Supervise remote vendor audits and ensure follow-up actions are completed.
• Maintain audit tracking systems and provide metrics for management review.
• Assist in regulatory inspections and provide GCP training as required.

Job Requirements

• Bachelor’s degree in Nursing, Health Science, or related field required.
• Minimum 15 years of experience in clinical auditing and compliance roles.
• Expertise in GCP auditing, including clinical reports, investigational sites, and vendor assessments.
• Knowledge of US and ICH GCP regulations and guidelines.
• Proficiency in clinical safety and trial management systems like ARISg and TrackWise.
• Strong interpersonal, communication, and organizational skills.
• Ability to manage competing timelines and work under pressure.
• Willingness to travel 40-60% for audits and collaborations.