Angitia Biopharmaceuticals

• Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met and that deliverables are completed on time and within budget. • Oversee the identification, selection, on-boarding, and management of study vendors including CROs, central /specialty labs, and imaging vendors etc. • Main point of contact for Full-service CRO, including all sub-contracted activities. • Provide study-specific training and direction/oversight to vendor personnel to ensure study delivery per the scope of work and key performance indicators. • Oversee and partner with external and internal stakeholders to ensure clinical trial data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’. • Contribute to clinical operations deliverables by providing updates (e.g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs). • Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring), and ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations. • Timely review and approval of invoices, monthly accruals, and forecast budget variances. • Review and approve monitoring reports per monitoring plan and escalate as needed. • Track key study activities using tracking tools. • Identify issues and risks and propose potential resolutions.

• Provide strategic leadership and hands-on oversight for the GxP Quality Management System, ensuring compliance with FDA, EMA, and ICH guidelines relevant to clinical‑stage activities. • Own the eQMS and its core modules, including governance, optimization, user support, and coordination with IT, internal stakeholders, and vendors. • Lead document management processes, ensuring controlled documents (SOPs, policies, forms, work instructions) are current, accurate, and aligned with clinical and CMO/CRO operations. • Oversee the GxP training program, including role‐based curricula, onboarding, training effectiveness, and system performance within the eQMS. • Direct the deviation and nonconformance process, ensuring high quality investigations, root cause analysis, and effective corrective and preventive actions. • Own the CAPA system, ensuring quality issues are captured, assessed, prioritized, and addressed with clear plans and effectiveness checks. • Manage change control processes for GxP documents, quality systems, and relevant operational changes. • Establish, monitor, and communicate Quality System KPIs to senior leadership; identify trends and drive proactive improvements. • Support internal and external audits, regulatory inspections, and inspection readiness activities. • Collaborate with CMO, CDMO, and CRO partners to ensure alignment and oversight of Quality System expectations, documentation, and compliance. • Contribute to Quality strategy and governance as the company advances into later‑stage clinical studies and early commercial readiness.

• Define and implement QC strategy aligned with company objectives. • Partner with Analytical Development, Quality Assurance, CMC, and Regulatory Affairs teams to ensure cross-functional alignment in program planning and execution. • Serve as the primary QC liaison with CTOs/CMOs, driving accountability and timely delivery. • Communicate program status, risks, and mitigation strategies to senior leadership. • Collaborate with CMC Ops to align QC deliverables (specifications, stability data, method validations) with manufacturing and supply chain timelines. • Identify potential risks and implications raised from QC data, and drive technical risk mitigation in collaboration with internal and external teams. • Oversee outsourced QC testing activities, including raw materials, in-process, release, and stability testing. • Establish KPIs and governance processes to monitor vendor performance. • Ensure QC activities comply with cGMP, ICH, FDA, EMA, and other relevant guidelines. • Review and approve QC documentation, including test methods, protocols, and reports. • Establish, maintain, and update product specifications in alignment with regulatory expectations. • Design and oversee stability programs for clinical and commercial materials. • Provide oversight of outsourced complex investigations, including out-of-specification (OOS), out-of-trend (OOT), and atypical results, ensuring robust root cause analysis and CAPA implementation. • Ensure method validation, transfer, and lifecycle management are executed to regulatory standards and program timelines. • Collaborate with Analytical Development to provide technical guidance on analytical methods (e.g., potency assays, binding assays, HPLC, ELISA). • Support regulatory submissions through review and/or authorship of relevant dossier sections.