• Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs. • Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements. • Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams. • Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations. • Review and manage deviations, CAPAs, and change controls associated with Clinical activities. • Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations. • Support continuous improvement initiatives across Clinical QA functions. • Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates. • Serve as a QA liaison between Clinical Operations, Regulatory Affairs, and external partners (CROs, Safety Vendors). • Support training and awareness of GCP and corporate quality policies across internal teams and contractors. • Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.