Neumora is hiring a
Director, Clinical Quality Assurance in Worldwide

Summary

The Director, Clinical Quality Assurance (cQA) will support Neumora's Clinical Quality Assurance program by ensuring compliance with global regulations, managing cQA consultants, performing audits, and collaborating on regulatory submissions. The role requires a strong understanding of GCP regulations, excellent communication skills, and 8+ years of experience in quality/regulatory compliance in the pharma/biotech industry.

Responsibilities

• Oversee the development, implementation, and oversight of GCP related QMS SOPs and Policies in compliance with all applicable regulations
• Ensure clinical trials are performed in accordance with applicable study protocols and global regulations as apply
• Manage cQA consultants and contractors
• Create/manage/maintain quality plans for the cQA department
• Perform and / or manage staff performing quality audits of investigator sites and clinical vendors
• Perform and / or manage quality reviews of clinical study documents, which include but are not limited to investigator brochures, clinical protocols and clinical study reports, case report forms, informed consents forms, DSURs, clinical study plans, protocol deviations, and protocol amendments
• Perform/manage internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP regulations, standards, and guidelines
• Provide expert CQA advice and strategic guidance to stakeholders (e.g., Clinical Operations, Clinical Development, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations
• Support the administration of the company’s training program by overseeing the conduct of GCP training to internal departments and externally, as applicable
• Manage/conduct targeted training of investigators/site staff
• Report GCP related deficiencies and associated risks to executive management as well as plans for risk mitigation and corrective and/or preventive actions (CAPA)
• Assist clinical study teams in the development of risk mitigation plans and CAPAs
• Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to executive management
• Coordinate responses to regulatory agency inspections
• Review regulatory submissions for clarity, accuracy, data integrity, and compliance to current applicable regulations
• Participate on Core Teams as the CQA program lead
• Create and drive performance to cQA goals and budgets