Senior Manager, CMC QA

Role: Senior Manager, CMC QA overseeing Product Complaints, Annual Product Quality Review, and Change Control programs within biopharmaceutical manufacturing. Objectives: Maintain strategic direction for QA manufacturing operations, ensuring compliance with GxP regulations and Ultragenyx standards. Responsibilities: Lead global quality review processes, manage change control review board, support product release and investigate quality events, facilitate audits/inspections, and drive continuous improvement initiatives. Develop and review CMC QA standards and procedures, ensuring regulatory compliance with FDA, EMA, and other authorities, including ICH guidelines. Requirements: Bachelor’s degree or equivalent in QA/manufacturing, with 8+ years’ GMP biopharma experience in technical operations or quality, including change control management and product disposition. Knowledge of regulatory expectations beyond FDA, such as EMA, ANVISA, and MHRA, and familiarity with product complaint investigations is preferred. Experience with GMP standards, quality systems, and cross-functional collaboration in manufacturing environments. High-value: Focus on quality assurance within biopharma manufacturing, regulatory compliance, GxP adherence, and continuous improvement. Work setup: Hybrid onsite role (2-3 days/week), with up to 10% travel.