• Support technology solutions provided by Genospace ensuring compliance with SOPs, FDA guidelines, ICH-GCP standards, and applicable regulatory requirements. • Lead and support Research Quality activities to ensure adherence to policies and procedures, ICH-GCP, FDA guidelines, and applicable local/federal regulations. • Contribute to the development and maintenance of policies, procedures, and controlled documents for Research Quality and supporting business units. • Assist in implementing risk-based quality support structures and tools to monitor compliance and performance. • Deliver training on quality assurance initiatives, regulatory compliance, and industry best practices. • Foster a culture of continuous improvement, patient safety, and data integrity. • Provide leadership in managing and sustaining robust document and change control programs. • Lead research quality processes to ensure compliance with SOPs, ICH-GCP, and local/federal regulations. • Serve as key subject matter expert and point of escalation with internal and external customers on all investigations and quality-related issues. • Assist with preparation for external audits, inspections, and quality oversight activities. • Support communication with sponsors and regulatory agencies as directed. • Contribute to inspection readiness activities and maintain compliance documentation.