Assoc Director, Quality Assurance

The Assoc Director, Quality Assurance will manage QA personnel responsible for batch review and lot disposition activities, including organizing and prioritizing group tasks, performing training, and writing performance reviews. They will perform a wide variety of activities to ensure compliance with applicable regulatory requirements, ensuring compliance with current Good Manufacturing Practices (GMPs). This role involves acting as an initial point of business escalation and providing guidance to staff, participating in developing Standard Operating Procedures (SOPs), ensuring the quality of products conform to established standards and agency guidelines, and working directly with operating entities to ensure inspections, audits, and statistical process control analyses are conducted. The position also requires interfacing with contract manufacturers to address performance or compliance issues, writing and/or implementing changes to controlled documents, and potentially specializing in transferring and driving quality initiatives across CMO organizations.