Clinical Quality Assurance Manager
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
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• 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
Apply tot his job
Apply To this Job