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.