Senior Director of GCP Clinical Quality Assurance

Nurix Therapeutics

Nurix Therapeutics

Sales & Business Development, Quality Assurance
San Francisco, CA, USA
Posted on Friday, May 17, 2024

Job Description

The Senior Director of GCP 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.

This role is instrumental in establishing, improving, and maintaining quality systems at Nurix and driving functional and cross-functional projects that embed continuous improvement principles across the company.

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.

Establish and maintain the Nurix GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.

Act as the primary business partner with internal organizations including Clinical Operations and Clinical Development.

Act as the primary contact for vendors, contract facilities and contract service providers related to quality aspects of clinical trials.

Oversee and 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 is the primary liaison with Health Authorities and Partners during internal audits and Health Authority inspections.

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 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

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