QA Senior Specialist, Supplier Quality - Hybrid, Redmond, WA

Role Summary

QA Senior Specialist, Supplier Quality — Hybrid, Redmond, WA. Drive supplier quality processes, audits, and collaborations to ensure patient safety and product quality while supporting regulatory inspections and supplier relationships.

Responsibilities

• Conduct supplier and material onboarding activities in accordance with approved procedures
• Conduct supplier onboarding audits and routine performance monitoring audits
• Conduct internal GMP Supplier Quality events (e.g., complaints, deviations, CAPAs) with escalation of critical issues affecting patient safety, product quality, or supply
• Assess supplier change notifications and initiate/process any follow-up actions necessary to determine impact and ensure compliance
• Negotiate and maintain quality agreements with service and material suppliers
• Conduct routine qualification of service and material suppliers
• Create, update and obsolete material specifications as needed
• Maintain supplier and material onboarding and performance documentation file
• Assess change controls for impact to supplier quality management
• Participate in raw material risk assessments
• Conduct investigations of supplier-related quality issues and root causes
• Other tasks as determined by management
• Travel expectation for on-site supplier audits and support of client audits and regulatory inspections at JEB sites

Qualifications

• Required: Bachelor‚Äôs degree with 6+ years in Quality and 8+ years in the biotech industry
• Required: Experience in Supplier Quality Management processes and methodologies
• Required: Knowledge of biologics and pharmaceutical regulations, risk management, and science-based decision-making
• Required: Project management experience
• Required: Proficiency in Microsoft Office and electronic quality management systems (e.g., Veeva QualityDocs, eQMS)

Skills

• Strong analytical and problem-solving abilities
• Effective communication and collaboration with cross-functional teams
• Ability to manage multiple tasks and meet deadlines
• Quality system and GMP compliance expertise

Education

• Bachelor‚Äôs degree (required as part of qualifications)

Additional Requirements

• Travel: On-site supplier audits and support of client audits and regulatory inspections at JEB sites