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 FDA data integrity expectations Verify that outsourced activities are controlled so the company can demonstrate to regulators that it retains accountability for work performed on its behalf Product Quality Complaints Own the product quality complaint handling program, ensuring written procedures and records meet 21 CFR § 211.198 and applicable ex-US requirements for investigational products Define intake, triage, risk classification, investigation, and closure requirements for complaints received from clinical sites, patients, distributors, CDMOs, and partners; ensure quality unit review and documented justification when no investigation is performed Ensure timely investigation, root cause analysis, and CAPA, and that complaint handling responsibilities and timelines are clearly defined in Quality Agreements with contract manufacturers and distributors Establish complaint trending and signal detection, and escalate adverse trends to management and, where applicable, to Regulatory Affairs, Clinical, and Pharmacovigilance/Drug Safety Recalls and Market Actions Own the product recall, retrieval, and market action procedures for clinical and (as applicable) commercial products, aligned with FDA guidance, and ex-US requirements Lead the cross-functional recall/crisis management team: determine recall need, support health hazard evaluations with Clinical, Medical, and Safety, define recall depth and strategy, and coordinate regulatory notifications and communications Plan and execute mock recalls and traceability exercises, including clinical supply retrieval from depots and investigational sites, and track lessons learned to closure Ensure recall effectiveness checks, reconciliation, and post-recall CAPA are completed and documented Inspection Readiness and Hosting Lead the company-wide regulatory inspection readiness program for FDA, EMA, MHRA, and other health authority inspections, including pre-approval inspections (PAIs) and BIMO inspections Maintain the inspection management process: front room/back room structure, storyboards, subject matter expert preparation and training, document request tracking, and daily debriefs Manage inspection observation responses (e.g., FDA Form 483 and equivalents), commitments tracking, and follow-up to closure Conduct readiness assessments, gap analyses, and mock inspections; apply lessons from internal and external audits and publicly available enforcement trends to strengthen readiness Prepare executives and cross-functional leaders for inspection participation Regulatory Intelligence Establish and maintain a structured regulatory intelligence process: monitor FDA, EMA, MHRA, PIC/S, ICH, WHO, and other authorities for new and changing GxP requirements, guidance, and enforcement trends Analyze FDA Warning Letters, Form 483 observations, and inspection outcomes for industry trends relevant to the company and its suppliers (e.g., complaint handling, data integrity, supplier oversight, CAPA effectiveness) Perform gap assessments of new requirements against current procedures; translate requirements into practical guidance, procedure updates, and training; and track implementation to completion Brief Quality leadership, CMC, and Regulatory Affairs on emer