Director, Clinical Quality Assurance

Overview

The Director, Clinical Quality Assurance is an integral part of the global Clinical Quality Assurance function, supporting the Iovance teams and the global quality systems. This includes ensuring clinical trials and associated records are complete and up to date in accordance with current Good Clinical Practices (GCP) and regulatory expectations and the maintenance of the quality management systems, such as SOPs, training and electronic records management. The Director, Clinical Quality Assurance will assist with regulatory inspection readiness, inspection management, and internal audits, including independent conduct of trial related audits.

Essential Functions and Responsibilities

• Maintain and support Clinical Quality Assurance (CQA) Systems: training, SOPs, and records management

• Provide support and expertise in GCP/Pharmacovigilance (PV) related regulatory inspections.

• Support proper maintenance of the clinical documentation databases and systems.

• Develop and supervise the GCP/PV related annual and project audit schedules.

• Perform or supervise GCP/PV related internal, vendor and investigator site audits.

• Perform periodic internal GCP trainings.

• Monitor CAPA execution to ensure accuracy and completeness.

• Generate and oversee quality metrics and advise management, as appropriate

• Represent CQA in assigned projects and cross functional groups to provide support and compliance for ongoing and planned clinical trials and initiatives.

• Support clinical development by reviewing and approving clinical documents and regulatory submission documents in accordance with Iovance procedures.

• Comply with all Corporate Policies, rules, and regulations as set out and communicated by the company pursuant to good business practice.

• Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business practices.

• Perform miscellaneous duties as assigned.

Travel

• Some travel required (up to 25%).

Required Education, Skills, and Knowledge

• BS in life sciences or equivalent experience

• 5+ plus years direct and relevant clinical quality assurance experience (GCP) in oncology studies.

• 10+ years in pharmaceutical/biotechnology industry and/or CROs,

• Broad knowledge of clinical processes and procedures, electronic document systems Good Clinical Practice and associated regulations.

• Experience with regulatory inspections and inspection readiness

• Direct GCP auditing experience

• Strong interpersonal, written and oral communication skills

• Must be able to build partnerships and diplomatically work with other departments.

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

Preferred Education, Skills, and Knowledge

• ASQ Certification

• Experience with European regulations is a plus.

• Experience with Pharmacovigilance QA is a plus

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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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 in a professional or remote office environment and requires operating standard office equipment and keyboards.

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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