The Manager of Quality Assurance (QA) is responsible for enhancing and maintaining elements of a QA function and Quality Management System (QMS) as required by current Good Manufacturing Practice (cGMP). This role works collaboratively with internal and external stakeholders to ensure cGMP compliance through the routine review/approval of manufacturing deliverables, conduct of audits and providing of quality advisement. The Manager of QA manages and tracks aspects of Idera’s quality system including controlled documents, training, audits, suppliers and metrics. This position reports to the Senior Director, Quality Assurance and is expected to operate with a high level of independence.
This role is an opportunity for a motivated, highly collaborative, and organized individual to impact the long-term value of Idera’s portfolio through efficient delivery of strategically-guided regulatory submissions. This role will also work closely with the cross-functional study/project team in contributing to the development of regulatory and overall product development strategies.