Auditor, Clinical Quality Assurance @Iovance

[Hiring] Auditor, Clinical Quality Assurance @Iovance

Apr 10, 2025 - Iovance is hiring a remote Auditor, Clinical Quality Assurance. 💸 Salary: unspecified. 📍Location: USA.

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Role Description

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.

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 commercial 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.

Qualifications

BA/BS or equivalent in life sciences or equivalent focus of study from an accredited university or college with 8+ years GCP relevant experience in an on-the-job decision-making role.
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.
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, MS Project).
Audit Certification/ CQA required with experience working in regulated environments specific to 21CFR Parts 50, 54, 56, and 312 a plus.

Requirements

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.

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.

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Auditor, Clinical Quality Assurance @Iovance

Salary 💸 unspecified	Remote Location USA
Job Type full-time	Posted Apr 10, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Auditor, Clinical Quality Assurance @Iovance

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