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Head of Clinical Quality Assurance
2 months ago
Position: Clinical Quality Assurance Director
Location: South San Francisco
Employment Type: Full-time direct hire; Hybrid role with 3 days onsite
The Clinical Quality Assurance Director is a pivotal role focused on ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards, and established Standard Operating Procedures (SOPs). This position plays a critical role in supporting clinical compliance and maintaining readiness for inspections, reporting directly to the Senior Director of Clinical Quality Assurance.
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 and service providers, ensuring quality standards are upheld.
- Oversee the quality of ongoing clinical programs, ensuring that appropriate assessments, monitoring, and risk management strategies are implemented.
- Evaluate clinical trial documentation to ensure data integrity and compliance with Good Clinical Practice and relevant regulations, including critical clinical and IND/NDA enabling documents.
- Provide quality assurance support for Health Authority Inspections and readiness activities, collaborating with service providers and CROs.
- Work closely with Clinical Development (including Pharmacovigilance/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics) to ensure overall GCP compliance and inspection preparedness.
Qualifications:
To excel in this role, candidates must meet the following qualifications:
- 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. Quality assurance professional certification is advantageous.
- A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
- Comprehensive understanding of risk-based quality systems aligned with ICH E6 (R2) for Good Clinical Practice, with experience across all phases of clinical trials.
- Familiarity with ICH E8 (R1) and its practical applications.
- Proficiency in interpreting and applying GCP, EU, FDA, and ICH regulations and guidelines, including a solid understanding of both domestic and international regulatory requirements.
