[Hiring] CSP Oversight Specialist II @Iovance Biotherapeutics

Role Description

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. Responsibilities include:

• 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

Some travel required (up to 20%).

Qualifications

• BS in life sciences or equivalent experience
• 5+ years of overall GCP or QA experience including 2+ years in service provider oversight
• Strong interpersonal, written and oral communication skills
• Exceptional organizational and critical thinking skills
• Must be able to build partnerships and diplomatically work with other departments
• Proficiency in the use of relevant computer systems including MS Office

Requirements

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects
• Must have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers
• Must be able to communicate with others to exchange information

Benefits

• Annual base salary: $110,000 — $120,000 USD

Company Description

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.