Senior Manager, Quality Operations

Nurix•Brisbane, CA

1d•Onsite

About The Position

The Senior Manager, Quality Operations is an important operational and technical contributor within the Nurix Quality organization, responsible for supporting the quality operations and GMP compliance activities that underpin Nurix’s clinical development programs. This role will partner closely with CMC teams, CDMOs, and internal stakeholders to ensure quality oversight across drug manufacturing, laboratory operations, auditing, and inspection readiness. Reporting to the Senior Director, Quality, the Senior Manager will execute essential quality systems activities including deviation management, change control, CAPA, batch record review, and audit support. This individual will demonstrate strong independent judgment, meticulous attention to detail, and the ability to collaborate effectively across functions in a dynamic, early to late clinical-stage environment where quality and program timelines are closely intertwined

Requirements

Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
7+ years of progressive Quality Assurance experience in clinical or commercial pharmaceutical or biopharmaceutical operations, with demonstrated hands-on responsibility for GMP quality systems
Strong working knowledge of GMP regulations and their practical application in CMC development and CDMO management (21 CFR Parts 210/211, ICH Q7, Q8, Q9, Q10, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines).
Hands-on experience with deviation investigations, CAPA management, change control processes, and batch record review and approval.
Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.
Experience supporting or conducting GMP audits of contract manufacturers and laboratory service providers; ability to write clear, comprehensive audit reports.
Familiarity with regulatory submission processes and experience reviewing or contributing to CMC sections of regulatory filings.
Proficiency with eQMS platforms, electronic document management systems, and Microsoft Office suite.
Strong attention to detail and organizational skills; demonstrated ability to manage multiple concurrent priorities and deliver against deadlines.
Excellent written and verbal communication skills; able to work effectively across functions and with external manufacturing partners.
Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.

Responsibilities

Execute and support quality systems operations for clinical development, including document management, deviation management, change control, CAPA, training, and validation activities.
Provide day-to-day quality oversight of CDMOs and contract laboratory operations, including review and approval of deviations, OOS/OOT investigations, batch records, specifications, sampling and testing plans, analytical methods, and lot disposition decisions.
Review and approve development, process transfer, and validation protocols and reports; verify process data in support of CMC regulatory submissions (INDs and NDAs).
Approve production-related activities including master batch records, change controls, stability study protocols and reports, and certificate of analysis reviews.
Participate in CMO selection, commissioning, qualification, and certification activities, support negotiation and maintenance of quality agreements with contract manufacturing partners.
Support risk management assessments of suppliers and manufacturing processes.
Manage and file quality documents in the electronic document management system; ensure timely completion of document lifecycle activities in compliance with internal procedures.
Support domestic and international GMP audits of contract manufacturers and laboratory service providers; collaborate cross-functionally with internal stakeholders to assess compliance with applicable regulations and Nurix SOPs.
Support internal quality audits to evaluate Nurix’s GMP compliance; document findings, prepare audit reports, and track corrective action commitments.
Communicate audit findings clearly to auditees and management; partner with auditees to develop thorough root cause analyses and CAPA plans.
Support preparation and coordination for regulatory agency inspections of Nurix and contract manufacturing partners, including pre-approval inspections (PAIs).
Assist with inspection logistics, document preparation, back-room operations, and response coordination during Health Authority GMP inspections.
Contribute to ongoing inspection readiness programs, including gap assessments, mock inspection activities, and training.