Clinical Quality Assurance Manager
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- Job Description:
- Serve as the CQA Lead for clinical programs.
- Set the vision for clinical compliance and ensure quality is integrated into study design and execution.
- Provide expert interpretation of FDA, ICH-GCP, EMA, and other regulatory requirements.
- Monitor the evolving regulatory landscape to ensure compliance and 'inspection-ready' operations.
- Qualify and manage clinical vendors (CROs, central labs) and oversee a risk-based site audit schedule.
- Serve as the primary point of contact for regulatory inspections.
- Provide strategic guidance on the investigation of significant quality events.
- Review and approve CAPA plans for effective remediation of systemic GCP issues.
- Review and provide final Quality approval for key clinical documents.
- Provide CQA performance metrics and trend analysis for Quality Management Reviews.
- Lead GCP training initiatives for clinical operations and cross-functional partners.
- Requirements:
- Bachelor’s degree in Biology, Chemistry, or other relevant scientific discipline required.
- Minimum of 8–10 years of experience in the pharmaceutical/biotech industry
- At least 5 years specifically in a GCP Quality Assurance lead role.
- Direct experience with Cell Therapy clinical studies is preferred.
- Proven track record of leading or playing a major role in successful regulatory inspections (FDA/EMA).
- Expert Knowledge: Deep mastery of 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6 (R2/R3).
- Benefits:
- Full health insurance to employees and their families
- 401(k) matching
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Generous Paid Time Off (PTO)
- Paid parking
- Subsidized commuter passes
- In-office catered lunches
- Team events
- Community projects