Senior Manager/Associate Director Clinical Quality Assurance Auditor

Nurix, Inc.; San Francisco (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a Senior Manager/Associate Director of Clinical Quality Assurance Auditor. This pivotal role involves managing the audit program, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. The ideal candidate will have extensive experience in GCP Quality Assurance auditing and a strong understanding of drug development processes. Join a forward-thinking organization dedicated to improving treatment options for patients with cancer and inflammatory diseases, where your expertise will play a crucial role in advancing clinical quality assurance.

Qualifications

• 5-8 years of GCP Quality Assurance auditing experience.
• Deep knowledge of drug development processes and global regulations.

Responsibilities

• Manage the audit program and conduct various audits.
• Ensure compliance with health authority regulations and guidelines.

Skills

GCP Quality Assurance Auditing

Analytical Thinking

Communication Skills

Regulatory Knowledge

Veeva or eQMS Systems

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

Job description

Senior Manager/Associate Director Clinical Quality Assurance Auditor

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Responsibilities and Duties:

The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal audits). This individual is responsible for implementing and maintaining a risk based, phase appropriate audit approach and ensuring clinical studies are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established quality standards and practices.

These responsibilities involve working closely with Clinical Operations, Clinical Development, 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 audit program, policies, and procedures.
• Responsible for developing and executing the annual QA audit plans for clinical vendor qualifications, routine vendor assessments/audits, clinical investigator site audits, internal audits of key development processes and audit of affiliates as appropriate.
• Conducting audits, writing audit reports and managing audit observations until closure
• Perform the review of trends, report significant quality issues and system deficiencies to senior management, as appropriate
• Act as the lead Clinical Quality assurance point of contact with internal organizations including Clinical Operations and Clinical Development and manage vendor related quality events as well as compliance related inquiries/escalations.
• 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, guidelines 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 and support inspection management.

Required Qualifications:

• Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy)
• 5-8 years GCP Quality Assurance auditing experience
• 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
• Reputation for incorporating strong analytical thinking in developing technical and/or business solutions to complex problems
• Willing to travel for up to 60%
• Previous experience with Veeva or other eQMS systems

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/ ).

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