CSP Oversight Specialist II

Iovance Biotherapeutics

7d • $110,000 - $120,000 • Remote

About The Position

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.

Requirements

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level