Remote
Clinical QA Specialist II, Clinical Specialist Providers (CSP)
About this role
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 Clinical QA Specialist II, Clinical Specialist Providers (CSP) who has experience in clinical service provider (CSP) qualification and oversight in Pharmaceutical and/or Biotechnology companies. The Clinical QA Specialist II, Clinical Specialist Providers (CSP) 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 be an innovative individual who takes ownership of CSP oversight to ensure GCP compliance with country/regional regulations and guidelines as well as the company’s policies and procedures. The successful candidate will possess exceptional organizational, critical thinking, and task prioritization skills, be a resourceful individual who is passionate about working with others in complex, changing, and fast-paced environments.
Essential Functions and Responsibilities Maintenance of the CSP qualification/requalification and oversight programs Completion of service provider qualification/requalification activities for a variety of CSPs (CROs, laboratories, imaging services, ethics committees, computer systems/software, etc.) Risk identification and mitigation for CSPs Service provider oversight from a CQA perspective, including interventions when the service provider is not performing as required (manage quality events, non-compliances, CAPAs, serious breaches, CSPCARs, etc.), and quality agreement negotiations Provide representation at study management team and CSP meetings Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics Perform miscellaneous duties as assigned Travel Some travel required (up to 20%).