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

• 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

Education and Qualifications

• 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)

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

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• 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 have visual acuity to perform activities such as preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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

• Some travel required (approximately 20%).

Work Environment

This job operates in a remote office environment and requires operating standard office equipment and keyboards.