Auditor - Clinical Quality Assurance

6 days ago

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Iovance Biotherapeutics, Inc.

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Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Iovance is seeking an Auditor, Clinical Quality Assurance. • Responsibilities include GCP investigational site, clinical service provider and GCP internal systems and processes audit activities. • Lead and support GCP/GCLP/GVP audits for investigational sites and clinical service provider audits. • Support and assist with commercial inspections, inspection readiness activities and other related activities. • Implement, enhance, and maintain procedures and work instructions based on best practices or compliance requirements. • Maintain a continuous process improvement initiative mindset in all areas of work. • Represent the Clinical Quality Assurance Team in cross-functional projects where applicable.

🎯 Requirements

• BA/BS or equivalent in life sciences or equivalent focus of study from an accredited university or college with 8+ years GCP relevant experience in an on-the-job decision-making role. • Current and working knowledge of pertinent United States Code of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA and/or other global/local government regulatory requirements. • 5 years of GxP audit experience. • Proven ability to manage multiple projects while maintaining quality. • Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally. • Working knowledge of MasterControl or other programs such as TrackWise, Veeva, or other related eQMS programs. • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project). • Audit Certification/ CQA required with experience working in regulated environments specific to 21CFR Parts 50, 54, 56, and 312 a plus.