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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.

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