• 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.