Senior Director, Quality Assurance

The Senior Director, Quality Assurance will partner with the VP QA to develop and implement comprehensive Quality Assurance strategies for pharmaceutical product manufacturing, testing, and release in accordance with GxP regulations. They will design and implement policies and practices to ensure GxP compliance, lead a quality culture, and ensure organizational processes conform with standard operating procedures. This role involves contributing to inspection and audit strategies, performing lot release activities, supporting the Quality Management System (QMS) for GMP, GLP, and GCP compliance, and collaborating with cross-functional teams to integrate quality processes. Responsibilities also include conducting risk assessments, supporting regulatory inspections and responses, establishing KPIs, driving training programs, and implementing continuous improvement initiatives. Additionally, the role supports IND and NDA CMC module authoring, vendor oversight, batch record review, deviation investigations, and compliance with applicable regulations such as FDA and ICH.