Senior Manager, eQMS Quality Systems – Onsite Brisbane

BioSpace; Brisbane (CA); Sur place; USD 159 000 - 172 000; Plein temps

Résumé du poste

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. Located in Brisbane, CA, the role centers on maintaining and improving QMS processes, deviations, CAPAs, and eQMS performance to ensure regulatory readiness.

You will collaborate with cross-functional teams to implement quality systems, monitor data integrity, and drive continuous improvement initiatives in a fast-paced

Qualifications

• Bachelor’s 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.

Responsabilités

• Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Complaints, Quality Metrics, and other core QMS programs.
• Led end-to-end implementation and deployment of Veeva Vault eQMS replacing legacy systems and aligning core quality processes across enterprise sites.
• 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.

Connaissances

Quality Systems

Quality Assurance

Regulatory compliance

Data governance

Attention to detail

Cross-functional collaboration

Formation

Bachelor's degree in Computer Science, Life Sciences, or a related field

Equivalent relevant experience

Outils

Veeva Vault eQMS

Microsoft Office Suite

Description du poste

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. Located in Brisbane, CA, the role centers on maintaining and improving QMS processes, deviations, CAPAs, and eQMS performance to ensure regulatory readiness.

You will collaborate with cross-functional teams to implement quality systems, monitor data integrity, and drive continuous improvement initiatives in a fast-paced