Auditor I, Clinical Quality Assurance

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.

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.

Pay Transparency$90,000—$100,000 USD

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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