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Clinical Quality Assurance Director

2 months ago

South San Francisco, California, United States GQR Full time

Position Title: Director of Clinical Quality Assurance

Location: South San Francisco

Employment Status: Full-time direct hire; Hybrid role with 3 days onsite

The Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards, Standard Operating Procedures (SOPs), and prevailing industry practices. This position is crucial for maintaining clinical compliance and readiness for inspections. The Director will report directly to the Senior Director of CQA.

Key Responsibilities:

  • Act as the representative for clinical quality during program team meetings, offering operational quality guidance to development teams.
  • Participate in operational meetings with CROs, service providers, and vendor quality discussions to uphold clinical quality standards.
  • Oversee quality assurance for ongoing clinical programs, ensuring that appropriate assessments, monitoring, risk evaluations, and mitigation strategies are effectively implemented.
  • Conduct reviews of clinical trial documentation to ensure data integrity and compliance with Good Clinical Practice and regulatory requirements, including essential clinical and IND/NDA enabling documents.
  • Provide clinical quality support during Health Authority Inspections, as well as during operational meetings with service providers and CROs, alongside inspection readiness initiatives.
  • Collaborate with Clinical Development (including Pharmacovigilance/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), CROs, and clinical sites to ensure comprehensive GCP compliance and readiness for inspections.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty. The qualifications listed below represent the necessary knowledge, skills, abilities, and prior experience required:

  • A Bachelor's degree with a minimum of 12 years of relevant experience or an advanced degree in a scientific discipline with at least 10 years of experience preferred. Certification in quality assurance is advantageous.
  • A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • Extensive knowledge of risk-based quality systems approaches in alignment with ICH E6 (R2) for Good Clinical Practice, with experience across all phases of clinical trials.
  • Familiarity with and practical application of ICH E8 (R1).
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines, including a comprehensive understanding of domestic and international regulatory requirements.