We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.
The Manager, Quality Compliance is responsible for ensuring our GxP Quality System developed meets all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and current Good Manufacturing Practices (cGMP), ICH and EMA regulations.
The Quality Compliance Manager will be responsible for disposition of Product for Translate Bio, inclusive of review and release of manufacturing/test documentation from process development, manufacturing and nonclinical, clinical and commercial processes and supply chains. This includes batch records, deviations, CAPAs, CoAs, CoCs, etc. The individual will be a key contributor with auditing and management of contract organizations such as CMOs, CROs, and CTLs.
Required Skills & Qualifications
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.