Senior Director of GCP Clinical Quality Assurance

Job Description

• Partnering with Clinical Operations to ensure that quality and compliance are integrated into long term strategies and day to day operations • Establishing, improving, and maintaining quality systems at Nurix and driving functional and cross-functional projects that embed continuous improvement principles across the company • Working closely with Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs, Clinical Trial Sites and laboratories • Responsible for inspection readiness related to GCP and is the primary liaison with Health Authorities and Partners during internal audits and Health Authority inspections • Conducting audits at Clinical Trial Sites, and Contract Research Organizations to ensure the compliant conduct of Nurix Sponsored clinical trials • Monitoring and managing current and projected quality issues with escalation to 89bio management for any potential issues of significance

Qualifications

• Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy) • 12 years of relevant biotechnology experience including 3+ years in an applicable Sr • 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

Benefits

• Not specified