Senior Manager Quality Compliance

Job Summary

Providing quality oversight for clinical trial activities, the full-time remote Senior Manager Quality Compliance will serve as a GCP Subject Matter Expert, manage risk-based audits, and support regulatory inspections within the Rare Disease therapeutic area.

Key responsibilities

• Serve as a GCP Subject Matter Expert, offering quality advice for clinical trial activities
• Plan and conduct risk-based GCP audits and manage regulatory inspections
• Support clinical program leaders in reviewing quality and compliance-related risks and issues

Required qualifications

• Doctorate degree with 2 years or Master's degree with 4 years of relevant experience in Quality, Operations, or Regulatory Compliance within the Pharma/Biotech sector
• Bachelor's degree with 6 years or Associate's degree with 10 years of relevant experience in the same fields
• High school diploma/GED with 12 years of relevant experience in Quality, Operations, or Regulatory Compliance
• Thorough knowledge of Good Clinical Practice (GCP) and international regulatory requirements
• Experience in conducting audits and managing quality in clinical trials