Responsibilities and Duties:
The Senior Manager of Clinical Quality Assurance is responsible for partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations. These responsibilities involve working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, Clinical Trial Sites and laboratories. This role may have future leadership responsibilities building out a team and require travel.
- Under the direction of the Executive Director of Clinical Quality Assurance, establish key processes and maintain the Nurix GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
- Act as the Clinical Quality assurance point of contact with internal organizations including Clinical Operations and Clinical Development and manage day to day compliance related inquiries/escalations.
- Act as the primary contact for vendors, contract facilities and contract service providers related to quality aspects of clinical trials.
- Manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities.
- Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.
- Responsible for writing and maintaining GCP SOPs and providing associated training
- Understanding and interpreting global regulatory agency policies and guidance and ensuring that Nurix adapts internal policies and procedures accordingly.
- Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.
- Responsible for inspection readiness related to GCP and support inspection management.
- Conducts audits at Clinical Trial Sites, and Contract Research Organizations to ensure the compliant conduct of Nurix Sponsored clinical trials.
- Monitors and manages current and projected quality issues with escalation to management for any potential issues of significance.
Required Qualifications:
- Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy)
- 3-8 years of relevant biotechnology experience including 3+ years in an applicable Sr
- 5-8 years GCP Quality Assurance experience
- Prior experience/in-depth knowledge of clinical quality assurance
- Experience working with CROs
- Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities
- Strong written and oral communication skills, strong skills in translating complex concepts across all levels of the organization
- Success working independently in a fast-moving start up environment
- Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems
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