Associate Director, Quality Assurance – Combination Products

The Associate Director, Quality Assurance will report to the Senior Director, Quality Assurance Drug Product and oversee the quality assurance for combination product projects from inception to commercialization. The ideal candidate will have a strong background in drug delivery systems, medical devices and combination product regulations. Exceptional organizational, clear communication, strong interpersonal skills, and strategic agility are essential for effectively conveying quality requirements to stakeholders across various functions and external partners. This role will involve collaboration with cross-functional teams and external partners to ensure that the combination product meets regulatory standards, are safe and effective for patient use.