Senior Manager, CMC QA

Role: Senior Manager, CMC QA responsible for overseeing Product Complaints, Annual Product Quality Review, and CMC Change Control Review Board programs, ensuring adherence to GxP regulations within biopharmaceutical manufacturing. Responsibilities include leading global quality review processes, managing Change Control Review Boards, supporting product release activities, and representing Ultragenyx during regulatory inspections. The role emphasizes continuous improvement, development of QA standards, and compliance with FDA, EMA, and other regulatory authorities. Qualifications: Bachelor's degree or equivalent in QA or related field; 8+ years of GMP biopharma manufacturing experience in quality or technical operations; expertise in Change Control processes, Product Disposition, and GMP standards; experience with regulatory audits and inspections. Preferred skills include knowledge of global regulatory expectations (EMA, ANVISA, MHRA), strong interpersonal skills, and experience with product complaint investigations. The position involves up to 10% travel, a flexible onsite work model (2-3 days/week), and offers a salary range of $174,900-$216,100 plus bonuses and incentives. High-value biopharma specifics: focus on GxP compliance, manufacturing quality systems, regulatory interactions, and continuous process improvements in a biologics or small molecule manufacturing environment.