Associate Director / Director, Supplier Quality and Audits
Core
Lead supplier audit management, vendor governance, compliance monitoring, and inspection readiness for GxP suppliers and service providers in a clinical-stage oncology company.
Role type
Director / Associate Director, Supplier Quality and Audits
Builds
Supplier Quality Compliance and Audit Program for outsourced GxP activities (CDMOs, CROs, labs)
Domain
Biotechnology / Oncology / GxP Quality Compliance
Required skills
Supplier qualification, risk classification, audit program management, quality agreement negotiation, CAPA management, regulatory inspection readiness, GxP auditing, vendor governance
Preferred skills
Virtual/outsourced manufacturing model experience, ASQ CQA/CMQ/OE/RQAP/ISO Lead Auditor/RAC certifications, travel for audits
Technologies
GxP regulations (FDA, EU, ICH), Quality Management Systems, audit tracking tools
Responsibilities
Lead supplier qualification, risk classification, onboarding, and ongoing monitoring of GxP vendors; Plan and conduct supplier audits and follow-up including CAPAs; Lead negotiation and lifecycle management of quality agreements; Support inspection readiness for outsourced GxP operations; Monitor supplier quality performance and escalate compliance risks; Develop and maintain supplier quality procedures and audit tools.
Seniority
Director level, strategic oversight with hands-on audit leadership