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Director, Clinical Quality Assurance Specialist

2 months ago

South San Francisco, California, United States GQR Full time

Job Summary

GQR is seeking a highly experienced Director of Clinical Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our clinical trials.

Key Responsibilities

  • Represent Clinical Quality at Program Team Meetings
    • Provide operational quality guidance to development teams

Represent Clinical Quality at CROs Operational Meetings, Service Provider Meetings, and Service/Vendor Quality Meetings

Provide Quality Oversight of Ongoing Clinical Programs

  • Ensure that the appropriate assessment and monitoring, risk assessment and risk mitigations are in place

Review Clinical Trial Documentation

  • Data integrity and compliance with Good Clinical Practice and regulations
  • Key clinical and IND/NDA enabling documents

Provide Clinical Quality Support for Health Authority Inspections, Service Providers, and CROs Operational Meetings

Collaborate with Clinical Development, Regulatory Affairs, and Development Operations

  • Support overall GCP compliance and inspection readiness

Qualifications

  • Bachelor's degree with 12 years' experience required or advanced degree in a scientific field with 10 years' experience preferred
  • Quality assurance professional certification is a plus
  • At least 5 years of experience in Clinical Quality Assurance or Clinical Operations
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice
  • Experience with all phases of clinical trials
  • Knowledge and practical application of ICH E8 (R1)
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines