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About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- Own the internal audit program end to end: annual, risk-based audit schedule, audit planning and scope, execution, reporting, CAPA verification, and program governance
- 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
More about this role
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.
- 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...
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