Director, Quality Assurance, Combination Products

Role: Director of Quality Assurance for Combination Products, overseeing design controls, risk management, and compliance from development through commercialization. Responsibilities: develop and implement quality strategies for combination products, ensuring adherence to global regulatory standards; collaborate with cross-functional teams including product development, manufacturing, regulatory affairs, and external partners; lead quality oversight of validation studies and product documentation; support regulatory audit processes and address audit observations; act as QA representative on product teams. Requirements: bachelor’s degree in biomedical, chemical engineering, pharmaceutical sciences, or related field; 10+ years’ experience in quality oversight of drug product and device development; proven expertise in design controls, combination products, and global standards (21 CFR Parts 803, 806, 820; ISO 13485, 14971; EU MDR). Preferred: experience with biologics and working CMOs. High-Value: biologics, combination products, device and drug regulation compliance, design control, risk management, validation, and global regulatory standards. WorkSetup: 5-15% travel domestically and internationally.