Senior Manager, electronic Quality Management System (eQMS)

Senior Manager electronic Quality Management System (eQMS)

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 Nurixs 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 medicines next chapter with a new script to outmatch disease.

Job Summary:

We are seeking a Senior Manager electronic Quality Management System (eQMS) to provide quality expertise supporting the development and commercialization of Nurixs products in compliance with relevant US EU and ICH this role you will be responsible for actively managing developing implementing and reporting on Quality Systems including Deviations Investigations CAPAs Change Controls Complaints Quality Metrics and electronic Quality Management Systems (eQMS). You will serve as a subject matter expert (SME) and strategic partner across Technical Operations Clinical Regulatory Affairs and other cross-functional teams with overall responsibility for the execution scalability and continuous improvement of Nurixs Quality Management System as the organization grows and matures.

Job Responsibilities:

• Manage and maintain processes SOPs and workflows for Deviations Investigations CAPA Change Control Complaints Quality Metrics and other core QMS programs.
• Lead or support the implementation configuration validation and optimization of the electronic Quality Management System (eQMS) ensuring phase-appropriate design and scalability.
• Provide hands-on expertise in the day-to-day execution review and management of QMS records within the eQMS.
• Partner with internal stakeholders to define data governance system configuration user roles and reporting requirements for quality systems.
• Ensure data integrity traceability and compliance of quality system data in accordance with regulatory expectations (e.g. ALCOA principles).
• Monitor overall quality system effectiveness identify gaps or inefficiencies and drive continuous improvement initiatives.
• Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness.
• Develop compile analyze and present quality metrics and KPIs for routine management review.
• Perform trending and data analysis to identify risks systemic issues and opportunities for improvement.
• Create and deliver training programs related to QMS processes data integrity and eQMS functionality.
• Support inspection readiness and ensure adherence to cGMPs regulatory mandates and internal quality standards.
• Build and maintain strong cross-functional relationships and foster a culture of engagement transparency and quality ownership.
• Perform other duties as assigned.

Experience and Skills:

• Bachelors degree in Computer Science Life Sciences or a related field or equivalent relevant experience.
• Demonstrated experience implementing administering and improving an eQMS including system configuration validation support and lifecycle management.
• Minimum of 6 years of experience in the pharmaceutical or biotechnology industry including 4 years in Quality Systems / Quality Assurance.
• Strong working knowledge of quality system data management reporting and data integrity principles.
• First-hand experience managing and reviewing deviations investigations CAPAs and change controls in a regulated environment.
• Experience using validated computerized systems to manage regulated quality records.
• Proven ability to develop and implement enhancements to electronic Quality Systems to improve usability compliance and reporting.
• Strong proficiency with Microsoft Office Suite and related business applications.
• Ability to manage multiple priorities in a fast-paced evolving environment with strong attention to detail.
• Highly organized self-motivated and capable of working independently while effectively collaborating cross-functionally.
• Excellent written and verbal communication skills with the ability to influence and interact effectively at all levels of the organization.

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view

Salary Range: $158700 - $172100

Location: Brisbane CA - Onsite