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      Director, Quality (GCP/GCLP/GVP)

      LARIMAR THERAPEUTICS

      Philadelphia, PA 19102

      OnsitePaid Time OffRetirement Benefit

      • A minimum of 10+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment
      • Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH)
      • Demonstrated ability to initiate process improvements and take initiative
      • Experience managing GCP/GCLP/GVP quality processes, including risk management activities
      • Ability to translate understanding to practice
      • Ability to work independently and collaboratively, as required, in a fast-paced environment
      • Demonstrated experience managing GCP inspections, including preparation and response activities
      • Bachelor's degree in life sciences
      • Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience
      • Strong attention to detail
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