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Remote
Remote only
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 an Auditor I, Clinical Quality Assurance, who has experience in GCP/GCLP/GVP/GMP compliance in Contract Research Organization (CRO), pharmaceutical and/or biotechnology companies.
This individual will be primarily responsible for assisting with GCP investigational site, clinical service provider, trial master file, and GCP internal systems and processes audit activities to ensure GCP, GCLP, and GVP compliance in accordance with US and EX-US regulations and guidelines, as well as the company’s policies and procedures. The successful individual may also assist with other CQA activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development. The selected team member should be innovative, energetic, collaborative, able to demonstrate critical thinking skills and express a strong desire to learn and take ownership and accountability for quality.
The successful candidate will be a key team member of a well-established organization who is passionate about working with others in complex, growing, changing, and fast-paced environments.
Essential Functions and Responsibilities
Education and Qualifications
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. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, critical thinking, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Travel
Work Environment
This job operates in a remote office environment and requires operating standard office equipment and keyboards.
The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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