Associate Director, Product Quality

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Product Quality based in the United States. We are seeking an experienced pharmaceutical quality leader to build, strengthen, and oversee quality systems supporting the development of innovative medicines. In this strategic and hands-on role, you will ensure compliance with GxP regulations while supporting product development, clinical manufacturing, and future commercialization activities. You will lead the implementation of a scalable Quality Management System (QMS) and provide quality oversight across internal operations and external manufacturing and research partners. Working closely with cross-functional teams, you will contribute to regulatory submissions, technology transfers, process validation, and product release activities. This opportunity offers the chance to shape quality strategy within a dynamic, collaborative, and fast-paced biotechnology environment. You will also mentor quality professionals, foster a culture of accountability, and help advance a promising pipeline of treatments with the potential to improve patients’ lives.