Manager, Product Quality

Role: Manager of Product Quality overseeing quality activities for development and commercial-stage products, ensuring compliance, performance, and continuous improvement throughout the product lifecycle. Responsibilities: lead product quality for assigned programs, investigate product complaints, support clinical operations and manufacturing campaigns, review deviations, investigations, CAPAs, and change controls, analyze quality trends, develop risk assessments, and support regulatory inspections and audits. Requirements: BS/MS in Life Sciences, 5-10 years pharmaceutical quality experience, knowledge of GMP manufacturing and quality systems, authorized to work full-time in the U.S. Additional preferences include problem-solving skills, technical depth, and interest in AI and digital innovation. HighValue: quality oversight across pharma development and manufacturing, compliance with GMP, support for regulatory submissions, cross-functional collaboration with Clinical Operations, Supply Chain, Manufacturing, and Regulatory teams. WorkSetup: full-time, based in the U.S., with a salary range of $66,000 - $169,400, plus bonus and comprehensive benefits.