Director of Quality Assurance, Clinical
Caribou Biosciences
August 16, 2026
Remote friendly (Berkeley, CA)
United States
$220,000 - $235,000 USD yearly
Clinical Research and Development
Summary:
Responsible for leading the development, implementation, and maintenance of QA systems and activities supporting quality oversight for GCP, GLP, and PV operations. Develop internal quality procedures, train staff, host regulatory inspections, manage clinical quality operations, and liaison on quality issues; perform audits of service providers, study sites, and internal processes.
Responsibilities:
- Ensure clinical trial activities comply with ICH-GCP, ICH-PV, applicable laws, and regulations.
- Review study documentation (protocols, investigator brochures, informed consent forms, CSRs) for GCP compliance.
- Provide GCP quality assurance leadership/SME to study teams; manage quality event documentation and CAPA plans.
- Support regulatory submissions and inspections; lead GCP inspection readiness and prepare teams for Pre-Approval Inspections (PAI).
- Implement/monitor Quality Assurance systems to meet FDA/EU/ROW and ICH requirements.
- Maintain and enhance QMS across the clinical trial lifecycle (GCP/GLP/PV).
- Develop and implement SOPs, quality manuals, policies, and quality documents; ensure stakeholder adoption.
- Create and implement clinical quality risk management strategies (assess, mitigate, oversee).
- Build and oversee quality system training curricula (pre-clinical, clinical, PV).
- Establish/monitor quality metrics and KPIs; report trends and improvements to senior management.
- Collaborate cross-functionally; maintain relationships with regulators and service providers.
- Perform internal/external audits; lead/manage additional GxP initiatives.
Qualifications:
- BS/MS in Biological Sciences, Chemistry, or related field; 15+ years clinical QA (GCP/GLP/PV) in cell & gene therapy/biotech and/or pharma (biologics strongly preferred).
- SME knowledge of CFR, ICH guidelines, and other regulatory requirements.
- Proven track record building/implementing clinical quality systems.
- Expertise creating audit plans (vendor, investigator site, CSV, process audits).
- Advanced QA knowledge; prior GLP auditing/oversight experience preferred.
- Strong communication, leadership, independent prioritization, and ability to manage multiple projects with attention to data.
- Diplomatic, tactful, critical reasoning; detail-oriented; proactive problem-solving.
- Flexible, able to multitask, meet deadlines, and adapt to setbacks.
- Desirable: Certified Quality Auditor and/or Certified Clinical Research Professional.
- Travel: up to 25–30%.
Benefits (as listed):
- Competitive salary, bonus, and equity
- Paid vacation and company-observed holidays
- Medical/dental/vision insurance
- 401(k) with employer match
- ESPP
- Tuition reimbursement program
Responsible for leading the development, implementation, and maintenance of QA systems and activities supporting quality oversight for GCP, GLP, and PV operations. Develop internal quality procedures, train staff, host regulatory inspections, manage clinical quality operations, and liaison on quality issues; perform audits of service providers, study sites, and internal processes.
Responsibilities:
- Ensure clinical trial activities comply with ICH-GCP, ICH-PV, applicable laws, and regulations.
- Review study documentation (protocols, investigator brochures, informed consent forms, CSRs) for GCP compliance.
- Provide GCP quality assurance leadership/SME to study teams; manage quality event documentation and CAPA plans.
- Support regulatory submissions and inspections; lead GCP inspection readiness and prepare teams for Pre-Approval Inspections (PAI).
- Implement/monitor Quality Assurance systems to meet FDA/EU/ROW and ICH requirements.
- Maintain and enhance QMS across the clinical trial lifecycle (GCP/GLP/PV).
- Develop and implement SOPs, quality manuals, policies, and quality documents; ensure stakeholder adoption.
- Create and implement clinical quality risk management strategies (assess, mitigate, oversee).
- Build and oversee quality system training curricula (pre-clinical, clinical, PV).
- Establish/monitor quality metrics and KPIs; report trends and improvements to senior management.
- Collaborate cross-functionally; maintain relationships with regulators and service providers.
- Perform internal/external audits; lead/manage additional GxP initiatives.
Qualifications:
- BS/MS in Biological Sciences, Chemistry, or related field; 15+ years clinical QA (GCP/GLP/PV) in cell & gene therapy/biotech and/or pharma (biologics strongly preferred).
- SME knowledge of CFR, ICH guidelines, and other regulatory requirements.
- Proven track record building/implementing clinical quality systems.
- Expertise creating audit plans (vendor, investigator site, CSV, process audits).
- Advanced QA knowledge; prior GLP auditing/oversight experience preferred.
- Strong communication, leadership, independent prioritization, and ability to manage multiple projects with attention to data.
- Diplomatic, tactful, critical reasoning; detail-oriented; proactive problem-solving.
- Flexible, able to multitask, meet deadlines, and adapt to setbacks.
- Desirable: Certified Quality Auditor and/or Certified Clinical Research Professional.
- Travel: up to 25–30%.
Benefits (as listed):
- Competitive salary, bonus, and equity
- Paid vacation and company-observed holidays
- Medical/dental/vision insurance
- 401(k) with employer match
- ESPP
- Tuition reimbursement program