Director Quality Assurance

Role: Director of Quality Assurance leading Site QA operations at a Cell Therapy manufacturing site, supporting facility start-up and routine production. Responsibilities: oversee investigations, assessments, deviations, CAPAs, change controls; develop and lead QA team; partner with senior leadership to ensure integrated Cell Therapy quality practices. Requirements: B.S. or M.S. in Science, Engineering, or Pharmacy; 8+ or 5+ years of relevant experience; minimum 5 years management; 2+ years in Cell Therapy/Biologics QA, including clinical lot release; experience with product launches, health authority inspections, global distribution; ability to operate in fast-paced, regulated environments; influence stakeholders. Preferred: advanced degree, extensive Cell Therapy GxP knowledge, experience with regulatory inspections and global bodies; proven talent development. HighValue: Cell Therapy, biologics, clinical lot release, GxP compliance, regulatory inspections, global manufacturing, start-up phase, senior stakeholder interaction. WorkSetup: hybrid with in-office presence at Rockville, MD; travel not specified.