Head of Clinical Quality Assurance
1 week 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 that demands a proactive approach to guarantee that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific), ICH guidelines, Standard Operating Procedures (SOPs), and prevailing industry practices. This role is essential for maintaining clinical compliance and ensuring readiness for inspections. The individual will report directly to the Senior Director of Clinical Quality Assurance.
Key Responsibilities:
- Act as the clinical quality representative during program team meetings, offering operational quality insights to development teams.
- Serve as the clinical quality liaison in meetings with CROs, service providers, and vendor quality discussions.
- Oversee the quality of ongoing clinical programs, ensuring that adequate assessments, monitoring, risk evaluations, and mitigation strategies are implemented.
- Examine clinical trial documentation to ensure data integrity and adherence to Good Clinical Practice and regulations, including critical 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, and facilitate inspection readiness activities.
- Collaborate with Clinical Development (including Pharmacovigilance/Safety), Regulatory Affairs, and Development Operations (covering Clinical Operations, Data Management, and Biostatistics), CROs, and clinical sites to uphold GCP compliance and readiness for inspections.
Qualifications:
To excel in this role, candidates must meet the following requirements:
- 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 is preferred. Certification in quality assurance is advantageous.
- A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations is required.
- 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 and practical application of ICH E8 (R1).
- Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines, demonstrating an understanding of both domestic and international regulatory requirements.
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