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.
60%- cGMP Quality Management
20%- Enterprise Quality Management
15% -Electronic Quality Management System Administration
5% -Regulatory Agency Inspection Support
· Bachelor’s degree in life sciences or related field; advanced degree preferred.
· Experience in drug manufacturing and analytical laboratory operations.
·Training and experience with international cGMP regulations; knowledge of GLP and GCP a plus.
·Experience in transitioning from clinical stage to commercial launch.
· Experience in virtual company environment a plus.