Clinical Quality Assurance Manager
2 weeks ago
We are seeking a highly skilled Senior Manager of Clinical Quality Assurance to join our team at Nurix Therapeutics, Inc. This role will be responsible for ensuring the quality and compliance of our clinical trials, working closely with Clinical Operations, Clinical Development, and other departments.
Responsibilities- Partner with Clinical Operations to integrate quality and compliance into long-term strategies and day-to-day operations.
- Work closely with 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.
- 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.
- 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 with escalation 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 process, 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 start-up environment.
- Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems.
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Clinical Quality Assurance Manager
4 weeks ago
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Senior Manager of Clinical Quality AssuranceNurix Therapeutics, Inc. is seeking a highly skilled Senior Manager of Clinical Quality Assurance to join our team. As a key member of our Clinical Quality Assurance department, you will be responsible for ensuring the quality and compliance of our clinical trials.Responsibilities:Partner with Clinical...
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Clinical Quality Assurance Manager
2 weeks ago
San Francisco, California, United States Nurix, Inc. Full timeJob Title: Senior Manager of Clinical Quality AssuranceNurix Therapeutics, Inc. is seeking a highly experienced Senior Manager of Clinical Quality Assurance to join our team. As a key member of our Clinical Quality Assurance department, you will be responsible for ensuring the quality and compliance of our clinical trials.Key Responsibilities:Establish and...
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Clinical Quality Assurance Manager
2 weeks ago
San Francisco, California, United States Nurix, Inc. Full timeClinical Quality Assurance Manager **Job Summary** We are seeking a highly experienced Clinical Quality Assurance Manager to join our team at Nurix Therapeutics, Inc. The successful candidate will be responsible for ensuring the quality and compliance of our clinical trials, working closely with Clinical Operations, Clinical Development, CMC, Medical...
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Clinical Quality Assurance Manager
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San Francisco, California, United States Nurix, Inc. Full timeJob Title: Senior Manager of Clinical Quality AssuranceNurix 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,...
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