Director of Raw Materials Quality - Site , 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

• 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

• 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

• 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

• 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