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. This role will involve collaboration with cross-functional teams and external partners to ensure that the combination product meets regulatory standards.
The Manager Manufacturing will be responsible for managing the manufacturing and import of medicinal products and investigational medicinal products in compliance with §12 AMWHV, GMP, and regulatory requirements. This role ensures timely batch review, product testing, documentation, and release to the Qualified Person, while helping to maintain GMP-compliant facilities, partners/suppliers and optimized processes. This person collaborates and actively works within Quality Assurance to manage deviations, CAPA, audits, and regulatory compliance.