Associate Director – QA – LAPI

Role: Associate Director – QA, supporting the startup of a new GMP manufacturing facility for APIs in Lebanon, IN. Objectives: ensure robust quality oversight, develop QA team, maintain compliance, and support manufacturing operations. Responsibilities: oversee quality systems, approve deviations and change controls, prepare for inspections, investigate complaints, and manage document revisions; collaborate cross-functionally for quality improvements and regulatory readiness. Requirements: BS in a scientific or engineering field; 5+ years in cGMP manufacturing, with knowledge of quality systems and regulations. Preferred: leadership experience in Manufacturing, QC, QA, or Regulatory Affairs; strong communication, problem-solving, and influencing skills; familiarity with statistical tools. HighValue: API manufacturing, GMP compliance, quality oversight of manufacturing and labs, cross-functional collaboration, experience supporting startup operations, may include travel; work schedule supports 24/7 operations. Location: Lebanon, IN, with some travel.