Senior Manager, Quality Assurance

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Manager, Quality Assurance based in the United States.

The Senior Manager, Quality Assurance will play a critical role in ensuring product quality, regulatory compliance, and commercial launch readiness within the pharmaceutical industry. This position focuses on quality oversight of transport validation and primary and secondary packaging validation for drug products and finished packaged products manufactured by contract manufacturing organizations (CMOs). You will collaborate with cross-functional teams to guide quality decisions and ensure alignment with global Good Manufacturing Practice (GMP) requirements. The role offers the opportunity to serve as a subject matter expert across deviations, corrective and preventive actions, change controls, and validation activities. You will also contribute to quality systems improvement, risk management, and the development of robust documentation and compliance practices. Working in a dynamic, deadline-driven environment, you will help strengthen inspection readiness and support the successful transition to commercial manufacturing.