Auditor I, Clinical Quality Assurance

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

📋 Description

• Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes, trial master file and clinical service provider audits. Responsibilities include the planning, coordination, and timely reporting of such audits as well as appropriate escalations of critical observations • Support and assist with commercial inspections, inspection readiness activities and other related activities as needed • Support GCP compliance activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development • Implement 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 1+ years GCP or 1+ years GMP experience • Knowledge of pertinent United States Code of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA and/or other global/local government regulatory requirements • 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 Veeva, or other related eQMS programs • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project).

🏖️ Benefits

• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. • 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 be able to remain in a stationary position standing or sitting for prolonged periods of time. • The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.