Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)

Role: Associate Director of Quality Assurance for regenerative organ manufacturing, overseeing QA strategy, compliance, and operational execution for a pre-clinical to IND-stage cellular therapy program at Research Triangle Park, NC. Responsibilities: develop and mature a phase-appropriate QMS, lead QA/QC team, ensure regulatory compliance (GMP, GTP, QSR), manage external vendor quality, support IND preparations, and drive continuous improvement. Collaborate closely with R&D, Process Engineering, Regulatory Affairs, and executive leadership to achieve regulatory milestones and inspection readiness. Requirements: Bachelor's in a scientific or technical field, 12+ years' related experience (10+ with Master’s), 6+ years managing teams, experience in regenerative medicine, tissue/organ manufacturing, regulatory submissions (IND/BLA), GMP/GTP knowledge, and vendor management skills. Preferred: Master’s degree, proficiency in quality systems tools (TrackWise, MasterControl), and knowledge of fetal tissue or human cell regulatory frameworks. HighValue: regenerative organ manufacturing, cell/tissue-based therapies, pre-IND/IND, GMP/GTP compliance, external vendor oversight, leadership in novel biopharma modalities. WorkSetup: in-person at RTP, NC, with travel to support external audits and collaborations.