Director, Quality Compliance and Supplier Quality

Nurix•Brisbane, CA

3d•Onsite

About The Position

The Director, Quality Compliance and Supplier Quality leads the programs that demonstrate and protect Nurix’s GxP compliance as the company advances through late-stage clinical development toward commercialization. The role is accountable for internal and external audit programs, supplier qualification and lifecycle management, product quality complaints, recalls and market actions, regulatory inspection readiness, and regulatory intelligence. It establishes risk-based oversight of CDMOs, contract laboratories, critical material and component suppliers, and other GxP service providers, ensuring outsourced activities are suitably controlled and the company retains accountability for work performed on its behalf. Reporting to the Senior Vice President, Quality Assurance and Compliance, the Director applies quality assurance and risk assessment principles, including ICH Q9 and ICH E6, to identify and communicate compliance risks and drive corrective actions to effective closure. The role has cross-functional accountability spanning Quality, CMC, Clinical Operations, Supply Chain/Procurement, Regulatory Affairs, and external partners. It leads a team of staff and contractors and combines strategic leadership with hands-on execution in a dynamic clinical-stage environment. The Director leads quality compliance strategy and governance; plans and executes internal and external audits; manages supplier qualification and ongoing oversight; owns complaint handling and recall readiness; and leads company-wide preparation for health authority inspections. The role also maintains regulatory intelligence, translates changing requirements into practical guidance and procedures, develops team capability, manages external consultants and auditors, and oversees compliance and supplier quality budgets and resources. The position is onsite in Brisbane, California, with domestic and international travel to CDMO, supplier, and laboratory sites as needed (estimated 10–20%).

Requirements

Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering, or a related field.
At least 10 years of progressive Quality Assurance or Quality Compliance experience in the pharmaceutical or biopharmaceutical industry.
At least 5 years leading audit, supplier quality, or compliance programs.
Demonstrated experience building or managing supplier qualification and audit programs, including oversight of CDMOs, contract laboratories, and CROs.
Thorough working knowledge of FDA regulations, including 21 CFR Parts 11, 210/211, 312, and 314; 21 CFR Part 7; relevant ICH guidelines; EudraLex Volume 4, including Chapter 7 and Annex 11; PIC/S guidance; and Regulation (EU) No 536/2014.
Proven experience with product complaint handling and CAPA programs in a clinical or commercial setting.
Experience supporting or leading regulatory agency inspections, such as FDA, EMA, or equivalent inspections.
Lead auditor experience for on-site and remote GxP audits, with strong report-writing and observation-classification skills.
Demonstrated ability to lead, develop, and motivate teams in a fast-paced, ambiguous environment.
Strong project management skills and ability to manage multiple high-priority deliverables simultaneously.
Strong verbal and written communication skills, including the ability to present complex compliance topics clearly to diverse stakeholders and executive leadership.
Willingness to travel domestically and internationally to CDMO, supplier, and laboratory sites as needed; estimated travel is 10–20%.

Nice To Haves

Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
Experience with electronic QMS platforms such as Veeva Vault QMS and document management systems.
Experience with GLP and GCP supplier oversight, clinical supply chains, and GDP requirements.
Professional certification such as ASQ Certified Quality Auditor (CQA), ASQ Certified Pharmaceutical GMP Professional (CPGP), or equivalent lead auditor training.
Experience supporting virtual or outsourced manufacturing models.

Responsibilities

Provide strategic leadership for the quality compliance program and maintain GxP compliance with FDA, ex-US regulatory authorities, and ICH guidelines across drug substance, drug product, clinical supply, and clinical activities.
Apply risk-based quality management principles, including ICH Q9(R1) and ICH E6(R3), to outsourced activities and GxP operations.
Maintain quality metrics, KPIs, and trend analyses, and present information at Quality Management Reviews and to executive leadership.
Escalate significant compliance risks with clear assessments and recommended actions.
Own the internal audit program, including the annual risk-based schedule, planning, scope, execution, reporting, CAPA verification, and governance.
Audit internal GxP processes and systems, track and trend observations, drive remediation, and verify corrective and preventive action effectiveness.
Establish auditor qualification, training, and independence requirements, and manage internal and qualified third-party auditors.
Establish and continuously improve the external GxP audit program, leading or coordinating on-site, remote, hybrid, for-cause, and pre-qualification audits.
Review supplier audit reports and responses, drive CAPAs to closure, and escalate unresolved risks to Quality leadership.
Support mock pre-approval inspections and pre-inspection audits at CDMOs, and coordinate with a Qualified Person or QP service provider as needed for EU/UK clinical certification.
Manage the audit calendar, resourcing, and budget; maintain audit reports and certificates in the eQMS; and support sponsor, partner, and licensing-partner audits of Nurix.
Own the GxP supplier and service-provider lifecycle, including selection support, risk classification, qualification, onboarding, performance monitoring, requalification, change management, and disqualification or exit.
Maintain the Approved Supplier List and supplier risk register, with documented qualification decisions.
Provide quality input to vendor selection and contracting; establish supplier scorecards, performance metrics, and periodic reviews; and lead supplier improvement plans where needed.
Extend supplier oversight to computerized systems and data-driven service providers, including data integrity and governance expectations.
Own the product quality complaint handling program, including intake, triage, risk classification, investigation, closure, quality unit review, and documented justification when no investigation is performed.
Ensure timely complaint investigations, root cause analyses, and CAPAs, and define complaint responsibilities and timelines in Quality Agreements.
Establish complaint trending and signal detection, and escalate adverse trends to management and relevant Regulatory Affairs, Clinical, and Pharmacovigilance/Drug Safety teams.
Own procedures for product recalls, retrievals, and market actions for clinical and, as applicable, commercial products.
Lead the cross-functional recall and crisis management team; support health hazard evaluations; determine recall depth and strategy; and coordinate regulatory notifications and communications.
Plan and execute mock recalls and traceability exercises, including retrieval of clinical supply from depots and investigational sites, and track lessons learned to closure.
Ensure recall effectiveness checks, reconciliation, and post-recall CAPAs are completed and documented.
Lead the company-wide regulatory inspection readiness program for FDA, EMA, MHRA, and other health authority inspections, including PAIs and BIMO inspections.
Maintain inspection management processes, including front-room/back-room structures, storyboards, subject matter expert preparation, document request tracking, and daily debriefs.
Manage responses to inspection observations, including FDA Form 483 and equivalents, and track commitments and follow-up to closure.
Conduct readiness assessments, gap analyses, and mock inspections; use audit findings and enforcement trends to strengthen readiness; and prepare executives and cross-functional leaders for inspections.
Establish and maintain regulatory intelligence covering new and changing GxP requirements, guidance, and enforcement trends.
Analyze Warning Letters, Form 483 observations, and inspection outcomes; assess new requirements against procedures; translate requirements into guidance, procedure updates, and training; and track implementation.
Brief Quality leadership, CMC, and Regulatory Affairs on emerging expectations and propose phase-appropriate approaches as the company moves toward commercialization.
Lead, develop, and mentor compliance, audit, and supplier quality professionals, setting expectations and building organizational capability.
Manage external consultants and third-party auditors, including their budgets and deliverable quality.
Build relationships with CMC, Regulatory Affairs, Clinical Operations, Supply Chain, Legal, Pharmacovigilance, and other internal partners.
Prepare and manage compliance and supplier quality budgets and resource plans.