Senior Director/Executive Director Of Clinical Quality

Job DetailExperience Level Executive DirectorDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000018497Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Drive clinical quality excellence in a hybrid executive role. Lead impactful audits and regulatory initiatives for compliance success. Collaborate across teams to enhance clinical program standards.Job DescriptionOverviewLead 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 & DutiesPlan, 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 RequirementsBachelor’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.