Director, Quality Compliance and Supplier Quality

Nurix•Brisbane, CA

5d•Onsite

About The Position

The Director, Quality Compliance and Supplier Quality is a leadership role within Nurix’s Quality organization, accountable for programs that demonstrate and protect the company’s GxP compliance across internal operations and outsourced activities. The role owns internal and external audit programs, supplier qualification and lifecycle management, product quality complaints, recall and market action readiness, regulatory inspection readiness, and regulatory intelligence. It ensures risk-based, inspection-ready oversight of CDMOs, contract laboratories, critical material and component suppliers, and other GxP service providers. Reporting to the Senior Vice President, Quality Assurance and Compliance, the Director applies quality assurance and risk assessment principles, including those in ICH Q9 and ICH E6, to identify and communicate compliance risks and ensure corrective actions are documented and effectively closed. The Director assesses contract acceptors’ suitability and competence, defines quality responsibilities in written agreements, and monitors outsourced work throughout product and clinical-trial lifecycles. This high-visibility position works across Quality, CMC, Clinical Operations, Supply Chain/Procurement, Regulatory Affairs, and external partners. It leads compliance and supplier quality professionals, including staff and contractors, and combines strategic leadership with hands-on execution as the company advances through late-stage clinical development toward commercialization while supporting early-phase pipeline assets. 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, 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, including 21 CFR Parts 11, 210/211, 312, 314, and Part 7; ICH guidelines E6(R3), Q7, Q8, Q9(R1), Q10, Q11, and Q12; 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 conducting GxP audits onsite and remotely, 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 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 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.

Responsibilities

Provide strategic leadership for the GxP quality compliance program across drug substance, drug product, clinical supply, and clinical activities, applying a risk-based framework informed by ICH Q9(R1) and ICH E6(R3).
Maintain quality metrics, KPIs, and trend analyses; present findings at Quality Management Reviews and to executive leadership, and escalate significant risks with recommended actions.
Own the internal audit program, including risk-based scheduling, planning, execution, reporting, CAPA verification, governance, auditor qualification, training, and independence requirements.
Audit internal GxP processes and systems, trend findings, drive remediation with process owners, verify CAPA effectiveness, and use results to prioritize quality improvements and inspection readiness.
Establish and improve the external GxP audit program; lead or coordinate supplier audits, review reports and responses, drive CAPAs to closure, escalate unresolved risks, and support mock pre-approval inspections and pre-inspection audits.
Coordinate with a Qualified Person or QP service provider as needed for EU/UK clinical certification; manage the audit calendar, resourcing, budget, records, and support audits conducted by sponsors, partners, and licensing partners.
Own end-to-end GxP supplier lifecycle management, including selection support, risk classification, qualification, onboarding, monitoring, requalification, change management, and disqualification or exit.
Maintain the Approved Supplier List and supplier risk register; provide quality input into vendor selection and contracting; establish supplier scorecards and reviews; and lead supplier improvement plans.
Extend supplier oversight to computerized systems and data-driven service providers, including data integrity and governance expectations, and ensure outsourced work is controlled while the company retains accountability.
Own the product quality complaint program, including intake, triage, risk classification, investigation, closure, quality unit review, complaint trending, signal detection, escalation, and complaint responsibilities in Quality Agreements.
Own procedures for product recalls, retrievals, and market actions; lead cross-functional recall response, support health hazard evaluations, coordinate notifications and communications, execute mock recalls and traceability exercises, and ensure effectiveness checks and post-recall CAPAs are documented.
Lead company-wide regulatory inspection readiness and hosting for FDA, EMA, MHRA, and other health authorities, including PAIs and BIMO inspections; manage inspection logistics, preparation, document requests, debriefs, observation responses, and commitments through closure.
Conduct readiness assessments, gap analyses, and mock inspections; prepare executives and cross-functional leaders for inspection participation and apply audit and enforcement-trend learnings.
Establish regulatory intelligence monitoring for relevant authorities and guidance; analyze inspection and enforcement trends, assess new requirements against current procedures, develop guidance and training, track implementation, and brief relevant leaders.
Lead, develop, and mentor compliance, audit, and supplier quality professionals; manage external consultants and third-party auditors; build cross-functional relationships; and manage compliance and supplier quality budgets and resource plans.