Auditor, Quality Assurance Compliance

Overview

Iovance is seeking an Auditor, Clinical Quality Assurance, who has experience in GCP/GCLP/GVP compliance in Contract Research Organization (CRO), pharmaceutical and/or biotechnology companies.

This individual will be responsible for GCP investigational site, clinical service provider 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 selected team member should be innovative, energetic, collaborative, and express a strong desire to learn and take ownership and accountability for quality.

The Auditor, Clinical Quality Assurance will support and oversee clinical quality assurance activities including investigational site, clinical service provider, and GCP internal systems and processes audits. 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

• Independently lead and/or support GCP/GCLP/GVP audits for investigational sites, GCP internal systems and processes 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 regulatory authority inspections, inspection readiness activities and other related activities as needed
• Assist in the review and approval of clinical change controls, clinical quality events, deviations, CAPAs, and clinical supplier corrective actions requests (C-SCARs).
• Implement, enhance, and maintain 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.

Required Education, Skills, and Knowledge

• Minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Current and working knowledge of pertinent United States Code of Federal Regulations, ICH Guidelines, EU, TGA, Health Canada, MHRA and/or other global/local government regulatory requirements
• 5 years of GxP audit experience or related experience from another clinical discipline
• 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 TrackWise, Veeva, or other related eQMS programs
• Strong computer skills including MS Office (Word, Excel, PowerPoint, )
• Audit Certification/ CQA required with experience working in regulated environments specific to 21CFR Parts 50, 54, 56, and 312 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

• 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

 Travel

• Some travel required (approximately 25%).

 Work Environment

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

#LI-remote 

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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