Clinical Quality Assurance Manager
3 days ago
Nurix Therapeutics, Inc. is seeking a highly skilled Senior Manager of Clinical Quality Assurance to join our team.
Responsibilities:- Partner with Clinical Operations to ensure quality and compliance are integrated into long-term strategies and day-to-day operations.
- Work closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, Clinical Trial Sites, and laboratories to ensure compliance.
- Establish key processes and maintain the Nurix GCP QA programs, policies, and procedures, ensuring 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.
- 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.
- Understand and interpret global regulatory agency policies and guidance, 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.
- Conduct audits at Clinical Trial Sites and Contract Research Organizations to ensure the compliant conduct of Nurix-sponsored clinical trials.
- Monitor and manage current and projected quality issues, escalating to management for any potential issues of significance.
- 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 Senior role.
- 5-8 years of GCP Quality Assurance experience.
- Prior experience/in-depth knowledge of clinical quality assurance.
- Experience working with CROs.
- Deep knowledge and understanding of drug development processes, global regulations, and interfacing related to GXP and GCP authorities.
- Strong written and oral communication skills, with the ability to translate complex concepts across all levels of the organization.
- Success working independently in a fast-moving startup environment.
- Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems.
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