Clinical Supplies Quality Assurance Specialist

The mission of Quality Assurance is to: safeguard the rights and well-being of patients; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies. Every breakthrough we create has the potential to build a healthier, more hopeful future for people everywhere. Patients are our purpose – that’s why we pursue the best science in our inventions and everything we do. This position is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Responsibilities may include but are not limited to the following:Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulationsCoordinate and/or support the preparation of procedures, processes and quality improvementsCompleting projects to improve the performance of our processes, including continuous process improvements, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle timesAssists in the coordination of significant quality events including fact finding, investigation supportCollaboration across IPT functional and business areas to ensure robust processing, continuous improvement and cross-functional team buildingActively using and championing the use of Lean Six Sigma (LSS) and client specific Production System tools, both in problem solving and day-to-day operational activities.