Overview
Iovance is seeking an Auditor I, Clinical Quality Assurance, who has experience in GCP/GCLP/GVP/GMP compliance in Contract Research Organization (CRO), pharmaceutical and/or biotechnology companies.
This individual will be primarily responsible for assisting with GCP investigational site, clinical service provider, trial master file, 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 successful individual may also assist with other CQA activities including investigations, clinical change controls, procedure development and review, ATC QA audits, and GCP training program development.
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.
- 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).
Travel
- Some travel required (approximately 20%).