Tubulis GmbH

• Create and maintain global GCP audit programs in collaboration with the Director QA-GCP. • Manage the vendor qualification program of assigned vendors. • Manage (planning, execution, and delivery) and/or oversee audit activities in the GCP area for all phases of clinical studies, suppliers, systems, and documents to assess compliance with Tubulis SOPs and applicable regulations and guidelines. • Identify compliance issues, communicate results to and educate auditees, project teams, and management. • Manage audit activities for GLP vendors and review and approve GLP quality documentation provided by vendor. • Provide GxP expertise in collaboration with relevant internal functions to identify, assess, and communicate quality-related risks and trends and improvement opportunities.

• Lead strategic initiatives to optimize clinical trial processes and drive operational efficiency across GCP-regulated activities. • Establish and maintain GCP-compliant process frameworks tailored to early-phase oncology trials. • Collaborate with cross-functional teams (e.g., Clinical Operations, Clinical Development, QA, Project Management) to identify process weaknesses, bottlenecks and implement process improvements. • Conduct gap analyses to identify potential business process and / or systems deficiencies. • Draft new SOPs and revise existing documents to reflect optimized, compliant and scalable practices. • Facilitate SOP review cycles, incorporating stakeholder feedback and ensuring alignment with internal policies and applicable regulatory requirements. • Analyze operational data and performance metrics to drive data-informed decision making and promote accountability. • Champion risk-based approaches in clinical operations, including proactive risk identification, mitigation planning, and CAPA oversight. • Support inspection readiness activities and serve in close collaboration with QA and the operational teams as a key contributor in internal audits and regulatory inspections.