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Key Responsibilities:
- Support GCP/GCLP/GVP audits for investigational sites, GCP internal systems, trial master file, and clinical service providers.
- Plan, coordinate, and report audits with timely escalations of critical observations.
- Assist with commercial inspections, inspection readiness, and other related activities.
Qualifications and Experience:
- BA/BS in life sciences or equivalent with 1+ years GCP or GMP experience.
- Knowledge of US CFR, ICH Guidelines, EU, TGA, Health Canada, MHRA, and other global regulations.
- Proven ability to manage multiple projects while maintaining quality and collaborating cross-functionally.
Work Environment and Physical Demands:
- Remote office environment with standard office equipment.
- Ability to remain stationary for prolonged periods and lift up to 10 pounds.
- Travel required approximately 20% of the time.
Pay and Commitment:
- Annual base salary range $90,000 - $100,000 USD, dependent on factors like location and experience.
- Iovance is an equal-opportunity employer committed to diversity and inclusion.
Iovance Biotherapeutics
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer patients. The company is a clinical-stage organization with a strong focus on innovation and collaboration in a fast-paced environment.