Senior Program Manager, Sterile NPI

The Senior Program Manager, Sterile NPI at Hims & Hers, will lead the entire lifecycle of sterile product launches, from initial conception through R&D to commercialization, ensuring alignment with 503A & 503B regulations and internal quality standards. Responsibilities include building and maintaining integrated project plans, presenting program updates to leadership, and maintaining project documentation. You will oversee formula development, method development, process development, tech transfer, and equipment validation activities. The role further entails working closely with the Quality team to align with USP and cGMP compliance standards, managing equipment onboarding and training, ensuring proper design control and product definition, overseeing facility and equipment qualification, ensuring documentation and quality readiness, overseeing operational and site readiness, and aligning with cross-functional teams on launch timing. You will support continuous improvement initiatives.