Assoc Director of QA - Vaccines

We are seeking an Associate Director of Quality Operations to join our Quality Assurance department who will provide Quality oversight to the development, manufacturing, testing, and release of clinical product through his/her direct efforts and/or the efforts of his/her reporting line. The Associate Director of Quality Operations will manage the product release function. In addition, the Associate Director of Quality Operations will provide leadership, coaching and performance management to his/her reporting line to develop the operational and analytical expertise of the team.
 

Responsibilities include but are not limited to:

? Act as liaison between Quality Assurance, Manufacturing, QC, and Development to provide quality leadership and expertise to ensure that product is developed, manufactured, tested, labeled, released and shipped to meet U.S. FDA current Good Manufacturing Practices (cGMP). This includes providing process audits and a Quality on the floor presence to ensure quality standards are maintained.

? Responsible for the review, release and status of production lots. This can include the review of executed batch production records and analytical data to assure technical and scientific completeness and compliance to cGMP requirements, and to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated and properly closed prior to product release.

? Review and approval of master batch records, product specifications, and testing plans.

? Approve or reject raw materials, components, product containers, closures, in-process materials, packaging materials, and labeling.

? Performs external audits of subcontractors, as necessary and in support to Quality Systems.

? Participate in regulatory inspections and maintain group in a state of inspection readiness.

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