Lakshmi V

• Proactive Quality Leadership for clinical project initiatives within the organization. Lead the oversight of all GCP, CSPV and quality and compliance activities including audits across the organization and ensure strategic alignment for GCP-QA, and in close partnership with other GxP QA functions (GCP/PV Audits, Quality Standards and Processes) • Develop, optimize and conduct complex initiatives such as proactive quality risk management and evaluation strategies in day-to-day activities. Identify continuous improvement processes, facilitate and implement global Quality Management Systems including document management systems and clinical development databases • Provide leadership and oversight of regulatory inspections, accountability plans, management and follow-up in collaboration with business functions and support local and global GCP inspections. Evaluate and monitor Health Authorities’ interpretation of regulations, guidance and commitments • Foster cross functional leadership and collaboration, conduct and support Clinical Research and Pharmacovigilance quality assessments, critical incidents including respective escalation process, CAPA management process for quality issues, audits and inspections in collaboration internal and external stakeholders. Advise senior management regarding continuous quality improvement initiatives, significant implications for compliance, provide quality assessment reports and metrics to align globally • Manage and build teams. Facilitate proactive communication and a collaborative quality culture and adapt to the evolving landscape of Clinical Quality. Collaborate and negotiate with peer groups, use a broader prospective to anticipate strategies and resolve conflicts on cross-functional issues while promoting a positive culture.