Associate Director, eQMS: Quality Systems & Compliance

Socket.dev

Brisbane (CA)

On-site

USD 201,000 - 234,000

Full time

5 days ago
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Job summary

Nurix Therapeutics is seeking an Associate Director, electronic Quality Management System (eQMS) to provide quality expertise supporting development and commercialization of Nurix products in line with US, EU, and ICH requirements. You will lead quality systems, including deviations, investigations, CAPAs, change controls, complaints, and eQMS, acting as SMEs with cross-functional impact.

You will manage, implement, and optimize the eQMS, ensure data integrity and traceability, and drive

Qualifications

  • Bachelor’s degree or equivalent in a relevant field.
  • 8+ years in pharma/biotech with 6+ years in Quality Systems.
  • Experience implementing and maintaining an eQMS.
  • Experience with data integrity and regulatory expectations.
  • Strong communication and cross-functional collaboration.

Responsibilities

  • Manage and maintain Deviations, Investigations, CAPA, Change Control, Complaints, Quality Metrics, and other core QMS programs.
  • Lead or support the implementation, configuration, validation, and optimization of the eQMS.
  • Provide day-to-day execution, review, and management of QMS records within the eQMS.
  • Define data governance, system configuration, user roles, and reporting requirements.
  • Ensure data integrity, traceability, and compliance of QMS data per regulatory expectations.
  • Monitor quality system effectiveness; identify gaps and drive improvements.
  • Recommend updates to quality policies and procedures and implement improvements.
  • Develop, compile, analyze, and present quality metrics and KPIs.
  • Perform trending and data analysis to identify risks and opportunities.
  • Create and deliver training on QMS processes, data integrity, and eQMS.
  • Support inspection readiness and adherence to cGMPs.
  • Build cross-functional relationships and foster a culture of quality ownership.
  • Perform other duties as assigned.

Skills

eQMS administration
Quality systems
Regulatory compliance
Change control
Deviation/Investigation handling
CAPA management
Data integrity
GxP awareness
Documentation
Cross-functional collaboration

Education

Bachelor’s degree in Computer Science, Life Sciences, or related field
Equivalent relevant experience

Tools

Microsoft Office Suite
eQMS software
Quality data systems

Job description

Nurix Therapeutics is seeking an Associate Director, electronic Quality Management System (eQMS) to provide quality expertise supporting development and commercialization of Nurix products in line with US, EU, and ICH requirements. You will lead quality systems, including deviations, investigations, CAPAs, change controls, complaints, and eQMS, acting as SMEs with cross-functional impact.

You will manage, implement, and optimize the eQMS, ensure data integrity and traceability, and drive

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