Manager, GCP Compliance

Overview

The GCP Compliance Manager will play an important role in ensuring GCP compliance in support of Iovance’s internal GCP audit program. This position partners with other departments such as Clinical Operations, Clinical Science, Clinical Data Management, Drug Safety and other teams to conduct, report upon and remediate internal audits of Iovance sponsored clinical trials to ensure compliance with applicable regulations and guidelines.

This position also supports investigational site audits and GCP service provider oversight and auditing activities.

Essential Functions and Responsibilities

·  Assist with the development and management of the GCP internal audit program.

·  Plan and perform GCP internal audits; issue audit reports, and track responses and remediation to closure.

·  Manage external contract auditors as needed.

· Ensure quality and compliance issues are addressed and clinical quality events, deviations, and CAPAs are tracked to completion while maintaining audit and associated clinical QA documentation.

· Review clinical protocols, investigator brochures, reports and other documentation to ensure compliance with regulatory requirements.

·  Support GCP QA regulatory Health Authority inspections such as the FDA and EMA, etc.

·  Generate quality metrics and advise management, as appropriate.

·  Participate in Quality Management Reviews and represent CQA in project teams.

·  Provide GCP support to teams as needed.

·  Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

·  Perform miscellaneous duties as assigned.

Travel

· Some travel required (approximately 15%).

Required Education, Skills, and Knowledge

·  8 years of Life Science related experience with a Bachelor’s degree.

·  Sound knowledge and understanding of global GCP regulations and guidance

·  2+ years direct and relevant GCP quality assurance experience.

·  Knowledge of FDA GCPs, EMA Regulations and ICH guidelines.

·  Strong interpersonal, written and oral communication skills.

·  Ability to manage competing priorities.

·  Proficiency in the use of relevant computer systems including MS office.

Preferred Education, Skills, and Knowledge

·  Oncology experience is a plus

·   Prior experience with regulatory inspections and inspection readiness is a plus.

Physical Demands and Activities Required

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.

·  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, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates primarily in a remote office environment and requires operating standard office equipment and keyboards. Occasion on site office work may be required.

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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