Director of Quality

Position Summary We are seeking a highly experienced and quality-focused Director of Quality to lead the Quality Assurance (QA) and Quality Control (QC) departments across our three regulated entities. Reporting to the executive team, the Director of Quality will oversee all aspects of our quality systems, ensuring regulatory compliance with FDA (including cGMP and 503B guidance) and State Boards of Pharmacy. This position is ideal for a strategic leader with strong technical acumen in sterile drug manufacturing and an unyielding commitment to patient safety, regulatory excellence, and cross-functional collaboration. The Director of Quality will play a critical role in inspection readiness, CAPA implementation, product release, deviation investigations, laboratory oversight, and the continuous improvement of our quality systems.