Director, Quality Compliance and Supplier Quality

Director, Quality Compliance and Supplier Quality Lead the Quality programs that keep Nurix inspection-ready as we advance through late-stage clinical development and toward commercialization. As Director, Quality Compliance and Supplier Quality, you’ll own the audit, supplier oversight, complaint, recall and inspection readiness programs that protect our GxP compliance across our CDMOs, contract laboratories and suppliers. This high-visibility role calls for both strategic leadership and hands-on execution. Position Description The Opportunity The Director, Quality Compliance and Supplier Quality is a leadership role within the Quality organization, accountable for the programs that demonstrate and protect the company’s state of GMP/GLP/GDP/GCP/GVP (collectively GxP) compliance: the internal and external audit programs, supplier qualification and lifecycle management, product complaint handling, recall and market action readiness, regulatory inspection readiness, and regulatory intelligence. This leader will ensure that the company’s reliance on contract development and manufacturing organizations (CDMOs), contract laboratories, critical raw material and component suppliers, and other GxP service providers is supported by a risk-based, inspection-ready oversight model. Reporting to the Senior Vice President, Quality Assurance and Compliance, the Director will apply quality assurance and risk assessment tools described in ICH Q9, ICH E6, and relevant regulations to identify and communicate compliance risks and ensure corrective actions are documented and driven to effective closure. The role is accountable for assessing and communicating outsourced-activity risks described in ICH and relevant global regulations: assessing the suitability and competence of each contract acceptor, defining quality responsibilities in written agreements, and monitoring performance over the lifecycle product or clinical trial. This is a high-visibility role with direct accountability across Quality, CMC, Clinical Operations, Supply Chain/Procurement, Regulatory Affairs, and external partners. The Director will lead a team of compliance and supplier quality professionals (contractors and staff) and is expected to operate both strategically and hands-on in a dynamic environment as the company advances through late-stage clinical development and toward commercialization while maintaining the agility necessary to introduce early phase assets into the pipeline. Quality Compliance Strategy and Governance Provide strategic leadership for the quality compliance program, ensuring GxP compliance with FDA, ex-US regulatory authorities, and ICH guidelines across drug substance, drug product, and clinical supply, and clinical activities Apply a risk-based compliance framework, applying ICH Q9(R1) and ICH E6 (R3) quality risk management principles to the assessment of outsourced activities and GxP operations Maintain quality metrics, KPIs, and trending (audit findings, supplier performance, complaints, CAPA effectiveness); prepare and present data at Quality Management Review and to executive leadership Escalate significant compliance risks, with clear risk assessments and recommended actions Internal Audit Program Own the internal audit program end to end: annual, risk-based audit schedule; audit planning and scope; execution; reporting; CAPA verification; and program governance Audit internal GxP processes and systems (e.g., deviation and CAPA management, change control, document control and records management, training, batch record and lot disposition review, data integrity, computerized systems, and clinical supply operations) Track and trend audit observations to identify systemic issues; drive remediation with process owners and verify effectiveness of corrective and preventive actions Establish auditor qualification, training, and independence requirements; manage internal auditors and any qualified third-party auditors Use audit results and trend data to prioritize quality system improvements and inform inspection readiness activities External Audit Program Establish, manage, and continuously improve the external GxP audit program with audit frequency and depth set by assessed risk Lead or coordinate on-site, remote, and hybrid audits, including for-cause and pre-qualification audits of Nurix suppliers; review audit reports, evaluate supplier responses, and drive CAPA to closure; escalate unresolved risk to Quality leadership Support mock pre-approval inspections and pre-inspection audits at CDMOs ahead of regulatory filings Coordinate with the Qualified Person (QP) or QP service provider as needed to support EU/UK clinical certification, including audit access and information requests Manage the audit calendar, audit resourcing, and budget; maintain audit reports and certificates in the eQMS Support sponsor, partner, and licensing-partner audits of the company, including response coordination and commitments tracking Supplier Qualification and Lifecycle Management Own the end-to-end supplier lifecycle for GxP suppliers and service providers: selection support, risk classification, qualification, onboarding, performance monitoring, requalification, change management, and disqualification or exit Maintain the Approved Supplier List (ASL) and supplier risk register, with documented evidence of each qualification decision Provide quality input into vendor selection, and contracting in partnership with CMC, Clinical Operations, Supply Chain, and Procurement Establish supplier scorecards, performance metrics, and periodic business and quality reviews; lead supplier development and improvement plans where performance falls short Extend supplier oversight to computerized systems and data-driven service providers (e.g., cloud/SaaS platforms, laboratory systems), including data integrity and data governance expectations consistent with EU GMP Annex 11 and