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The Quality Control Senior Analyst II will perform data review, manage critical document tracking, and serve as a point of reference to ensure that content in regulatory filings matches source documentation. The role involves collaboration with both internal and external partners to define and manage the ongoing cGMP testing of cell and gene therapy products from pre-clinical through post-approval lifecycle management. The analyst will contact subject matter experts and relevant parties to recover documents required for regulatory submissions and background source information. As the Point of Contact with the Contract Testing Lab, the analyst will build partnerships and oversee testing progress and deadlines. Responsibilities include reconciling documents against project plans to assure targets have been met, managing the movement of documents from SharePoint to a Document Repository, verifying data in regulatory submissions, creating and managing datasets, and collaborating with in-house quality counterparts and CxOs. The analyst will monitor CxOs oversight activities and assess for continuous improvement, work with internal and external subject matter experts to manage and resolve scientific, technical, or quality issues, and participate in client meetings regarding sample data management as the Quality Control SME. The position allows for telecommuting up to 40%.
