About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics , Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com .
Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com .
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%).
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…