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 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%).

Required Education, Skills, and Knowledge

• 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

Physical Demands and Activities Required

• 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

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, administration, critical thinking and task prioritization skills, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.