Senior Manager, CMC QA

Role: Senior Manager, CMC QA responsible for overseeing Product Complaints, Annual Product Quality Review, and Change Control Review Board programs within biopharmaceutical manufacturing, ensuring compliance with GxP regulations. Responsibilities include leading global quality review processes, managing change control activities, supporting product release, driving continuous improvement initiatives, developing QA standards, investigating product complaints, and representing Ultragenyx during regulatory inspections. Qualifications: Bachelor's degree or equivalent in QA or related field; 8+ years of GMP biopharma experience in technical operations and quality, with expertise in Change Control and Product Disposition. Preferred skills include experience with regulatory authorities (FDA, EMA, etc.), strong knowledge of GMPs, and familiarity with product complaint investigations. High-Value: Focus on biopharma with an emphasis on rare disease products, GxP compliance, and cross-functional collaboration in quality and manufacturing. Work setup: Hybrid model requiring 2-3 onsite days weekly; up to 10% travel.