Director of Raw Materials Quality - Site Based, Redmond, WA

Director, Raw Materials Quality What You’ll Do Lead the Raw Materials Quality function, including QC Raw Materials Testing, Raw Material Lot Disposition, and Supplier Quality Management Manage and develop managers and team leads responsible for day-to-day operations Ensure effective execution of raw material quality activities to support manufacturing timelines Establish and monitor functional goals, KPIs, and performance metrics Promote a culture of quality, accountability, and continuous improvement Escalate quality, compliance, and supply risks to senior leadership as appropriate Implement and maintain robust processes for raw material qualification, supplier qualification and monitoring, incoming material sampling and testing, and raw material lot disposition Apply risk-based approaches to raw material control aligned with regulatory expectations Support development and lifecycle management of raw material specifications and control strategies Drive continuous improvement in raw material quality, reliability, and testing turnaround times Provide oversight of QC raw material testing to ensure compliance with GMP requirements Ensure materials are sampled, tested, and reviewed per approved procedures and timelines Oversee analytical testing programs (e.g., FTIR, HPLC, pH, etc.) and ensure methods are qualified/verified as required Ensure timely resolution of QC investigations (e.g., OOS, deviations, atypical results) Oversee external laboratory testing where applicable Oversee QA disposition of raw materials to ensure compliance with cGMP requirements and ensure timely release to support manufacturing Ensure appropriate review of certificates of analysis, supplier documentation, analytical testing results, and qualification status; ensure disposition decisions are documented in quality systems Lead Supplier Quality activities across the supplier lifecycle (qualification, monitoring, requalification) Oversee supplier audits and ensure timely closure of observations Manage supplier-related quality events (deviations, complaints, CAPAs, change controls) Monitor supplier performance metrics and drive improvements Ensure all activities comply with FDA, EMA, ICH, and internal quality systems; adhere to deviations, CAPAs, and change control Support regulatory inspections and internal audits; identify and elevate compliance risks and support corrective actions Monitor and report KPIs (testing turnaround time, material disposition cycle time, supplier performance, investigation timelines) Drive continuous improvement and support implementation of scalable systems and processes Experience 8+ years in Quality, QC, or Supplier Quality in a GMP-regulated pharmaceutical/biotechnology environment 5+ years of leadership experience managing technical or quality teams Experience supporting biologics manufacturing across clinical and/or commercial stages Experience with raw material testing, supplier quality, and material disposition processes Technical Knowledge Strong knowledge of cGMP regulations and regulatory expectations (FDA, EMA, ICH) Understanding of raw material control strategies in biologics manufacturing Familiarity with analytical testing methods for raw materials Experience with quality and laboratory systems (eQMS, LIMS, ERP) Knowledge of supplier qualification and auditing practices Skills and Competencies Strong leadership and team management Effective cross‑functional collaboration Solid problem‑solving and decision‑making Ability to manage competing priorities in a GMP environment Strong communication and organizational skills Attention to detail and commitment to quality Benefits (as stated) Base pay range: $141,120 to $193,200 (salary exempt) Discretionary annual bonus Medical, Dental, Vision Short‑term and long‑term disability Company‑paid basic life insurance 401k company match Paid time off and paid holiday Wellness and transportation benefits #J-18808-Ljbffr