CSP Oversight Specialist II

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview 

Iovance is seeking a CSP Oversight Specialist II who has experience in clinical service provider (CSP) qualification and oversight in Pharmaceutical and/or Biotechnology companies.

The CSP Oversight Specialist II is an integral part of the global CQA function, supporting both Iovance teams and CSPs. This includes ensuring that CSPs are appropriately assessed/periodically reassessed using a risk based methodology to ensure that they are able to meet/continue to meet Iovance’s needs, assessing/mitigating the risks associated with the use of CSPs, and providing general oversight from a CQA perspective, including quality event review/assessment, quality agreement negotiation, implementation and management of CSP corrective action requests (CSPCARs). S/he will