QA/QC Manager - DPF

Role: The QA/QC Manager oversees operational leadership of the microbiology and environmental monitoring programs at the DPF facility supporting xenotransplantation organ manufacturing. Responsibilities: govern microbiology and environmental monitoring, lead deviation and CAPA processes, manage supplier qualification, ensure inspection readiness, and support quality system initiatives including audits, risk assessments, and regulatory interactions. Requirements: 8+ years in GMP/QSR regulated environment with a Bachelor's or 6+ years with a Master's degree; strong knowledge of GMP/QSR, FDA regulations, GxP principles, and microbiology operations; experience supporting regulatory inspections and managing controlled documentation; proven problem-solving and risk assessment skills. Preferred: experience with IND submissions, TrackWise, MasterControl, and implementing QMS. HighValue: focus on xenotransplantation, advanced therapeutic products, regulatory inspection support, environmental monitoring governance, and microbiology quality oversight in a biopharma manufacturing setting.