Angitia Biopharmaceuticals

Director

• 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.

Senior Director, Quality Control