Petersburg, VA30+ days ago
The essential functions include, but are not limited to the following: Establish, implement, and continuously improve site-level sterility assurance control strategies, including environmental monitoring, contamination control, personnel qualification, and aseptic process simulation programs, in alignment with cGMP regulations and current industry guidance (e.g., USP, EU Annex 1, FDA Aseptic Processing Guidance). The Associate Director – Sterility Assurance will work closely with cross-functional site teams including Manufacturing, Quality Assurance, Engineering, and Regulatory Affairs to ensure that sterility assurance programs are robust, compliant, and fit for purpose for a high-speed parenteral manufacturing environment.