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 emerging expectations, and propose phase-appropriate approaches as the company moves toward commercialization

Leadership and Collaboration

- Lead, develop, and mentor a team of compliance, audit, and supplier quality professionals; set clear performance expectations and build organizational capability for commercialization readiness

- Manage external consultants and third-party auditors, including budget and quality of deliverables

- Build trusted relationships with internal partners in CMC, Regulatory Affairs, Clinical Operations, Supply Chain, Legal, and Pharmacovigilance

- Prepare and manage the compliance and supplier quality budget and resource plans

What You’ll Bring

Required Qualifications

- Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, engineering, or a related field

- 10+ years of progressive Quality Assurance or Quality Compliance experience in the pharmaceutical or biopharmaceutical industry, including 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 (21 CFR Parts 11, 210/211, 312, 314), 21 CFR Part 7 (recalls), and ICH guidelines (E6(R3), Q7, Q8, Q9(R1), Q10, Q11, Q12), as well as EudraLex Volume 4 (including Chapter 7 and Annex 11), PIC/S guidance, and Regulation (EU) No 536/2014 (Clinical Trials Regulation)

- Proven experience with product complaint handling and CAPA programs in a clinical or commercial setting

- Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent)

- Lead auditor experience for GxP audits (on-site and remote) with strong report-writing and observation-classification skills

- Demonstrated ability to lead, develop, and motivate teams in a fast-paced, ambiguous environment

- Excellent project management skills and the ability to manage multiple high-priority deliverables simultaneously

- Strong verbal and written communication skills; able to present complex compliance topics clearly to diverse stakeholders, including executive leadership

- Willingness to travel to CDMO, supplier, and laboratory sites domestically and internationally, as needed (estimated [10-20]%)

Preferred Qualifications

- Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization

- Experience with electronic QMS platforms (e.g., Veeva Vault QMS) and document management systems

- Experience with GLP and GCP supplier oversight, and with clinical supply chain and GDP requirements

- Professional certifications 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

Location:        Onsite – Brisbane, CA

Fit with Nurix Culture and Values

- You lead through complexity: you bring clarity, judgment, and calm to high-stakes compliance decisions, earning trust from your team, your suppliers, and your cross-functional partners

- You are a builder and a connector: you see quality compliance as an enabler of scientific progress and patient outcomes, not a gatekeeper function, and you work collaboratively to solve problems at their source

- You invest in your team: you recognize that a capable, engaged Quality organization is foundational to our mission, and you take developing others as seriously as you take regulatory compliance

About Nurix Therapeutics

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.